Prosthesis and method for widening the palpebral fissure of an individual&#39;s eye

ABSTRACT

A prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface. The prosthesis is configured to widen the natural palpebral fissure of a wearer&#39;s eye. The prosthesis may have an aperture widening zone located on the convex surface and including an area of increased surface friction. A method of widening the natural palpebral fissure of a wearer&#39;s eye is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.14/018,244, titled “Eye Aperture Enhancing Prosthesis and Method,” filedon Sep. 4, 2013. This application claims priority to the following U.S.Provisional Patent Applications via U.S. application Ser. No.14/018,244, all of which are hereby incorporated by reference in theirentirety:

Ser. No. 61/698,205, titled “Novel Lid Lifting Contact Lens Design andUse,” filed Sep. 7, 2012;

Ser. No. 61/702,274, titled “Novel Cosmetic Contact Lens,” filed Sep.18, 2012;

Ser. No. 61/706,827, titled “Novel Cosmetic Eye Widening Contact Lens,”filed Sep. 28, 2012;

Ser. No. 61/714,567, titled “Cosmetic Eye Widening Contact Lens,” filedOct. 16, 2012;

Ser. No. 61/716,633, titled “Fitting Method and Contact Len Design ofInventive Palpebral Fissure Widening Contact Lens,” filed Oct. 22, 2012;

Ser. No. 61/721,530, titled “Contact Lens Design for Widening PalpebralFissure of Wearer's Eye,” filed Nov. 2, 2012;

Ser. No. 61/726,096, titled “Improved Contact Lens Design for WideningPalpebral Fissure of Wearer's Eye,” filed Nov. 14, 2012;

Ser. No. 61/729,020, titled “Palpebral Fissure Widening Contact Lens.”filed Nov. 21, 2012;

Ser. No. 61/730,185, titled “Palpebral Fissure Widening Contact Lens,”filed Nov. 27, 2012;

Ser. No. 61/736,210, titled “Enhanced Palpebral Fissure Widening ContactLens,” filed Dec. 12, 2012;

Ser. No. 61/757,365 titled “Corneal Scleral Contact Lens for PalpebralWidening,” filed Jan. 28, 2013;

Ser. No. 61/835,709, titled “Palpebral Fissure Enhancing Scleral Ring,”filed Jun. 17, 2013; and

Ser. No. 61/859,360, titled “Eye Aperture Enhancing Prosthesis,” filedJul. 29, 2013.

This application is a continuation-in-part of International ApplicationPCT/US2013/058175, titled “Eye Aperture Enhancing Prosthesis andMethod,” with an international filing date of Sep. 5, 2013, which ishereby incorporated by reference it its entirety:

This application claims priority to the following U.S. ProvisionalPatent Applications, all of which are hereby incorporated by referencein their entirety:

Ser. No. 61/940,676, titled “Prosthesis For Widening Small Eye PalpebralFissures,” filed Feb. 17, 2014;

Ser. No. 61/979,535, titled “Palpebral Widening Soft Contact LensesComprising Different Overall Diameters,” filed Apr. 15, 2014;

Ser. No. 62/024,154, titled “Eye Aperture Widening Prosthesis HavingCombined Elements,” filed Jul. 14, 2014; and

Ser. No. 62/053,837, titled “Novel Design of Eye Aperture WideningProsthesis Having Combined Elements,” filed Sep. 23, 2014.

BACKGROUND OF THE INVENTION

Field of the Invention

The present application relates to prostheses for use in the eye. Inparticular, the present application relates to prostheses that enhanceor alter the appearance of a wearer's eye.

Background

It is known that the aperture of the human eye (i.e., largest verticaldistance between an individual's upper lid and lower lid) reduces inoverall diameter by 1.5 mm or more as one matures from that of a childto that of an adult of the age of 40 and even more as one matures tothat of a senior of 60 years or older. In addition to a reduction inaperture size due to old age, some individuals suffer fromblepharoptosis, also referred to as ptosis, which is defined as anabnormal low-lying upper eyelid margin within the eye in primary gaze.In some instances, ptosis is correctable by surgery. Moreover, someindividuals may desire a larger eye aperture for cosmetic purposes.

Traditional corneo-scleral contact lenses (soft contact lenses or hybridcontact lenses) that fit on the cornea of one's eye (do not vault thecornea) and extend over the limbus and bulbar conjunctiva thus coveringpart of the sclera are not being used for correcting ptosis and/or thewidening of the wearer's palpebral fissure. This is due to theirgeometrical design. Also corneal contact lenses (rigid or soft) that fitonly the cornea and do not extend past the limbus are not used forcorrecting ptosis and/or the widening of the wearer's palpebral fissuredue to geometrical design and overall diameter. Scleral contact lensesare hard/rigid and have been designed in the past to fit snugly againstthe sclera of the wearer's eye, “vault the cornea” and have a very thickedge design such to lift the upper lid of the wearer's eye havingptosis. While scleral contact lenses have existed in the past that willlift the upper lid of the wearer's eye these hard/rigid sclera contactlenses are highly uncomfortable, cause very red eyes and irritate theeye lid margin thus presenting severe limitations for the wearer. Forthese reasons the commercial success of scleral contact lenses tocorrect for ptosis has been a major failure. Thus non-surgical andcomfortable means to widen the natural palpebral fissure of anindividual's eye are of interest.

SUMMARY OF THE INVENTION

Some embodiments include a prosthesis, such as a corneo-scleral contactlens, for enhancing the look of a wearer, whereby the prosthesisincludes a colored region that is one of: a colored ring, limbal ring,color enhanced iris area, accent color located over a portion of thelimbus of the wearer's eye and whereby the prosthesis includes a surfacefeature designed to increase the distance between the upper lid marginand the lower lid margin of the eye of the wearer. In some embodiments,the prosthesis increases the vertical palpebral measurement of thewearer by at least 1 mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface and a concave surface. Theprosthesis has an aperture widening zone located on the convex surface.The prosthesis widens the natural palpebral fissure of the wearer's eyeby at least 1 mm. The invention disclosed herein is targeted toward eyeshaving a small palpebral fissure having a vertical dimension of 9.0 mmor less. The invention disclosed herein works well for Asian eyes.Additional features of the invention disclosed herein, by way of exampleonly is that of increased surface friction that pertains to anyprosthesis that widens the vertical dimension of any sized eye aperture(palpebral fissure)

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. Theprosthesis is a corneo-scleral contact lens that widens the naturalpalpebral fissure of the wearer's eye by at least 1 mm.

Some embodiments include a prosthesis having a convex surface and aconcave surface. An aperture widening zone is located on the convexsurface. The prosthesis is a scleral ring that widens the naturalpalpebral fissure of the wearer's eye by at least 1 mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. The aperturewidening zone includes at least one surface feature. The prosthesiswidens the natural palpebral fissure of the wearer's eye by at least 1mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface, a concave surface, and a peripheraledge. The prosthesis also has an aperture widening zone located on theconvex surface. The aperture widening zone including an outer slope andan inner slope with a maximum change in thickness located in between.The outer slope and the inner slope are different.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface, a concave surface, and a peripheraledge. The prosthesis also has an aperture widening zone located on theconvex surface. The aperture widening zone including an outer slope andan inner slope with a maximum change in thickness located in between.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. The aperturewidening zone has at least one surface feature. The aperture wideningzone also has a minimum vertical dimension.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface, a concave surface, aperipheral edge, and a geometric center. An aperture widening zone islocated on the convex surface. The aperture widening zone has at leastone surface feature. At least a portion of the at least one surfacefeature is located at or outside 5.25 mm from the geometric center ofthe prosthesis.

In some embodiments the prosthesis has an overall diameter of at least13.0 mm. In other embodiments the prosthesis has an overall diameter ofat least 13.5 mm. In some embodiments the prosthesis has an overalldiameter of at least 14 mm. In some embodiments the prosthesis has anoverall diameter of at least 14.5 mm. In some other embodiments theprosthesis has an overall diameter of at least 15.0 mm or larger. Insome other embodiments the prosthesis has an overall diameter of atleast 15.5 mm. In some other embodiments, the prosthesis has an overalldiameter of at least 16.0 mm.

In some embodiments the prosthesis is a rotationally symmetric lens. Insome embodiments the prosthesis is capable of rotating. In someembodiments the prosthesis is not capable of rotating.

In some embodiments the aperture widening zone depresses a lower eye lidof the wearer by at least 1 mm. In some embodiments the aperturewidening zone elevates an upper eye lid of the wearer by at least 1 mm.

In some embodiments the prosthesis includes a colored accent color. Insome embodiments the colored accent color is around a portion of theprosthesis which fits near or at the limbus of the eye when theprosthesis is worn. In some embodiments the colored accent color is alimbal ring, circle ring, or circle lens.

In some embodiments the prosthesis is a multifocal contact lens. In someembodiments the prosthesis is a toric contact lens. In some embodimentsthe prosthesis is a single vision contact lens.

In some embodiments the aperture widening zone comprises an area ofincreased surface friction. In some embodiments the increased surfacefriction is provided by a surface treatment, a coating, a differentmaterial, surface dimples, surface irregularities, chemical treatment,etching, or combinations thereof.

In some embodiments the aperture widening zone also includes an outerslope and an inner slope with a maximum change in thickness located inbetween. In some embodiments the outer slope and inner slope aredifferent. In some embodiments the outer slope is greater than the innerslope. In some embodiments the outer slope has an angle between 3° and45°. In some embodiments the outer slope has an angle between 5° and25°. In some embodiments the inner slope comprises an angle between 1°and 15°.

In some embodiments the aperture widening zone has an incrementalthickness and a maximum change in thickness. In some embodiments themaximum change in thickness is within a range of 25 microns to 1,000microns. In some embodiments the maximum change in thickness is within arange of 100 microns to 500 microns. In some embodiments the maximumchange in thickness is within a range of 75 microns to 400 microns. Insome embodiments the maximum change in thickness is located between 1.0mm and 2.5 mm from an outer edge of the prosthesis. In some embodimentsthe maximum change in thickness is located at or exterior to the corneallimbus of the wearer's eye when the prosthesis is worn on the eye. Insome embodiments, the maximum change in thickness is located at least5.5 mm from the geometrical center of the prosthesis (i.e., at least onehalf the diameter of the average human cornea, which is 11-12 mm). Insome embodiments, the maximum change in thickness is located at least6.0 mm from the geometrical center of the prosthesis. In someembodiments, the maximum change in thickness is located at least 6.5 mmfrom the geometrical center of the prosthesis. In some embodiments theincremental thickness is an increase in thickness. In some embodimentsthe incremental thickness is a decrease in thickness.

In some embodiments an outermost part of the aperture widening zone islocated within a range of 3 mm to 8.5 mm from a geometric center of theprosthesis. In some embodiments an outermost part of the aperturewidening zone is located within a range of 5 mm to 7.75 mm from ageometric center of the prosthesis. In some embodiments an innermostpart of the aperture widening zone is located between a peripheral edgeof the prosthesis and 6 mm from a peripheral edge of the prosthesis.

In some embodiments a minimum vertical dimension of the aperturewidening zone is larger than a maximum vertical diameter of the naturalpalpebral fissure of the wearer's eye. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 8.0 mm. In other embodiments the minimum vertical dimension of theaperture widening zone is equal to or greater than 8.5 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 9.5 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 9.5 mm. In some embodiments a minimum vertical dimension of theaperture widening zone is equal to or greater than 10.0 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 10.5 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 11.0 mm. In some embodiments a minimum vertical dimension of theaperture widening zone is equal to or greater than 11.5 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 12.0 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is a vertical distancebetween an uppermost part of the aperture widening zone and a lowermostpart of the aperture widening zone.

In some embodiments the aperture widening zone includes at least onesurface feature. In some embodiments the aperture widening zone has aplurality of surface features.

In some embodiments the prosthesis is a corneo-scleral contact lens. Insome embodiments the prosthesis is a scleral ring.

In some embodiments the aperture widening zone has a minimum verticaldimension.

In some embodiments the prosthesis also has a peripheral edge, ageometric center, and at least one surface feature. In some embodimentsthe at least one surface feature or at least a portion of the at leastone surface is located at or outside 5.25 mm from the geometric centerof the prosthesis. In some embodiments the peripheral edge has a knifeedge shape, a rounded shape, a blunt shape, or a semi-rounded shape. Insome embodiments the peripheral edge has a thickness between 25 micronsand 100 microns.

In some embodiments the prosthesis has a hybrid design. In someembodiments the prosthesis has a homogeneous design.

In some embodiments the aperture widening zone comprises a ring,multiple rings, a partial ring, multiple partial rings, an island,multiple islands, a band, bands, partial bands, a segmented area, ormultiple segmented areas.

In some embodiments the prosthesis can be worn by the wearercontinuously. In some embodiments the prosthesis can be worn by thewearer non-continuously. In some embodiments the prosthesis can be wornby the wearer daily, weekly, or monthly.

In some embodiments the prosthesis is disposable. In some embodimentsthe prosthesis is reusable.

In some embodiments the prosthesis comprises an optical power. In someembodiments the prosthesis does not comprise an optical power.

Some embodiments include a prosthesis having an aperture widening zone.The aperture widening zone has an outer slope, an inner slope, a pointof maximum added thickness delta, and an incremental thickness diameter.The prosthesis also has a peripheral edge, a geometrical center, and anoverall diameter. The overall diameter is measured from a first point onthe peripheral edge to a second point on the opposing peripheral edgethru the geometrical center of the prosthesis and the aperture wideningzone. The overall diameter is 14.5 mm or greater. The outer slope iswith the range of 5 degrees and 25 degrees. The point of maximum addedthickness delta of the aperture widening zone is 75 microns or greater.The point of maximum added thickness delta of the aperture widening zoneis located between 1 mm and 3 mm from the peripheral edge. Theincremental thickness diameter is 8.5 mm or greater. In someembodiments, the incremental thickness diameter is 10.5 mm or greater.

In some embodiments the prosthesis is free to rotate. In someembodiments the prosthesis is not free to rotate.

In some embodiments the incremental thickness diameter is 1 mm largerthan the vertical measurement of the natural aperture of the wearer'seye. In some embodiments the incremental thickness diameter is at least1 mm larger than the vertical measurement of the natural aperture of thewearer's eye.

In some embodiments the prosthesis is a single vision contact lens. Insome embodiments the prosthesis is a multifocal contact lens. In someembodiments the prosthesis is a toric contact lens.

In some embodiments the prosthesis includes a hydrogel. In someembodiments the prosthesis includes a silicone hydrogel. In someembodiments the prosthesis includes a homogenous material. In someembodiments the prosthesis includes hybrid materials.

In some embodiments the aperture widening zone begins at or adjacent tothe peripheral edge. In some embodiments the aperture widening zonebegins internal to the peripheral edge.

In some embodiments the point of maximum added thickness delta is 100microns or greater. In some embodiments the point of maximum addedthickness delta is 125 microns or greater. In some embodiments the pointof maximum added thickness delta is 150 microns or greater. In someembodiments the point of maximum added thickness delta is 200 microns orgreater. In some embodiments the point of maximum added thickness deltais 225 microns or greater. In some embodiments the point of maximumadded thickness delta is 250 microns or greater.

In some embodiments the prosthesis is one of: daily wear, disposable,continuous wear, weekly wear, or monthly wear.

In some embodiments the prosthesis is not stabilized.

In some embodiments the aperture widening zone is a round ring. In someembodiments the aperture widening zone is a series of partial segmentsthat make up a ring.

Some embodiments provide for a method of widening the natural palpebralfissure of a wearer's eye by providing a protocol or instructions forwidening the wearer's natural palpebral fissure by at least 1 mm andproviding at least one prosthesis comprising an aperture widening zonelocated on its convex surface. In some embodiments the protocol orinstructions include directions to determine a vertical dimension of thewearer's natural palpebral fissure, and to provide the wearer with aprosthesis having a minimum vertical dimension at least 1 mm greaterthan a maximum vertical dimension of the natural palpebral fissure.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer including a convex surface, a concave surface, and anaperture widening zone located on the convex surface and including anarea of increased surface friction, where the aperture widening zone hasa minimum vertical dimension of greater than or equal to 8 mm and isconfigured to widen the natural palpebral fissure of a wearer's eye.

In some embodiments, the area of increased surface friction has afriction drag coefficient that is greater than the fiction dragcoefficient of a portion of the convex surface adjacent to the area ofincreased surface friction. In some embodiments, the area of increasedsurface friction has a friction drag coefficient at least 1% greaterthan the friction drag coefficient of a portion of the convex surfaceadjacent to the area of increased surface friction. In some embodiments,the area of increased surface friction has a friction drag coefficientat least 25% greater than the friction drag coefficient of a portion ofthe convex surface adjacent to the area of increased surface friction.

In some embodiments, the aperture widening zone includes a plurality ofareas of increased surface friction.

In some embodiments, the prosthesis has an overall diameter of at least13.0 mm.

In some embodiments, the area of increased surface friction is flat andtakes on the normal curvature of the convex surface of the prosthesis.In some embodiments, the area of increased surface friction is raisedrelative to a normalized front convex surface of the prosthesis.

In some embodiments, the area of increased surface friction is providedby a surface treatment, a coating, a different material, surfacedimples, surface irregularities, chemical treatment, etching, or acombination thereof.

In some embodiments, the prosthesis also includes a color enhancingregion. In some embodiments, the color enhancing region providesincreased surface friction. In some embodiments, the color enhancingregion at least partially overlaps with the aperture widening zone. Insome embodiments, the color enhancing region comprises at least one of:a continuous colored ring, a non-continuous colored ring, a coloredzone, a uniform color, multiple colors, multiple shades of a singlecolor, and an accent color.

In some embodiments, the aperture widening zone also includes an area ofincreased thickness, and wherein the area of increased thicknessincludes an outer slope and an inner slope with a maximum change inthickness located in between. In some embodiments, the maximum change inthickness is between 25 microns and 1,000 microns.

Some embodiments provide for a method of widening the natural palpebralfissure of an individual's eye including (a) measuring the verticaldimension of the natural palpebral fissure of an individual's eye, and(b) providing to the individual a first prosthesis comprising anaperture widening zone with a minimum vertical dimension at least 1 mmgreater than the individual's natural palpebral fissure. In someembodiments, the method includes (c) re-measuring the vertical dimensionof the palpebral fissure of the individual's eye while the individual iswearing the first prosthesis. In some embodiments, the method includes(d) determining whether the vertical dimension of the palpebral fissureof the individual's eye has been widened by at least 1 mm relative tothe measurement in step (a). In some embodiments, the method includes(e) repeating steps (b)-(d) with different prostheses comprising anaperture widening zone with a minimum vertical dimension greater thanthe minimum vertical dimension of the first prosthesis until theindividual's palpebral fissure is widened by at least 1 mm relative tothe measurement in step (a).

In some embodiments, the method includes providing to the individual aprosthesis that, when worn, results in the individual having a palpebralfissure with a vertical dimension at least 1 mm greater than thevertical dimension of the individual's natural palpebral fissure.

In some embodiments, the measurement in step (a) is determined by atleast one of: taking a photograph of the individual's eye and measuringthe vertical dimension of the individual's palpebral fissure in thephotograph, physically measuring the vertical dimension of theindividual's palpebral fissure, visually estimating the verticaldimension of the individual's palpebral fissure, fitting a trialprosthesis having markings that indicate one or more vertical dimensionson the individual's eye, and fitting a trail prosthesis having a knowndiameter on the individual's eye.

In some embodiments, the measurement in step (e) is determined by atleast one of: taking a photograph of the individual's eye and measuringthe vertical dimension of the individual's palpebral fissure in thephotograph, physically measuring the vertical dimension of theindividual's palpebral fissure, visually estimating the verticaldimension of the individual's palpebral fissure, fitting a trialprosthesis having markings that indicate one or more vertical dimensionson the individual's eye, and fitting a trail prosthesis having a knowndiameter on the individual's eye.

In some embodiments, the measurement in step (a) is performed while theindividual's eyes are relaxed and the individual is not smiling. In someembodiments, the measurement in step (e) is performed while theindividual's eyes are relaxed and the individual is not smiling.

In some embodiments, the minimum vertical dimension of the firstprosthesis is chosen based on the vertical dimension of the naturalpalpebral fissure of the individual's eye. In some embodiments, theminimum vertical dimension of the first prosthesis is no greater than 1mm larger than the vertical dimension of the natural palpebral fissureof the individual's eye. In some embodiments, the aperture widening zoneof the first prosthesis has a minimum vertical dimension of greater thanor equal to 8 mm.

Some embodiments provide for a method of widening the natural palpebralfissure of an individual's eye including providing to an individual aprosthesis comprising an aperture widening zone having a minimumvertical dimension at least 1 mm greater than the individual's naturalpalpebral fissure.

Some embodiments provide for a method of widening the natural palpebralfissure of an individual's eye including providing instructions to widenthe palpebral fissure of an individual's eye, the instructionscomprising the steps of: measuring the vertical dimension of theindividual's natural palpebral fissure and providing to the individual aprosthesis comprising an aperture widening zone with a minimum verticaldimension at least 1 mm greater than the individual's natural palpebralfissure.

In some embodiments, the measurement for the vertical dimension of theindividual's natural palpebral fissure is determined by at least one ofthe following: taking a photograph of the individual's eye and measuringthe vertical dimension of the individual's natural palpebral fissure inthe photograph, physically measuring the vertical dimension of theindividual's natural palpebral fissure, visually estimating the verticaldimension of the individual's natural palpebral fissure, fitting a trialprosthesis having markings that indicate one or more verticaldimensions, and fitting a trail prosthesis having a known diameter.

It will be appreciated that various embodiments recited above withrespect to the prosthesis and/or aperture widening zone can be combinedin any combination, except where features are mutually exclusive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an individual having congenital ptosis on the right eye.

FIG. 2 illustrates a visual field that shows functional blockage due toa ptotic lid.

FIGS. 3-7 illustrate various individuals afflicted by ptosis.

FIGS. 8-11 illustrate various individuals with wide eyes that are notafflicted by ptosis.

FIGS. 12A-B show a prosthesis having an aperture widening zone accordingto one embodiment superimposed on the eyes of an individual.

FIGS. 13A-B show a prosthesis having an aperture widening zone accordingto one embodiment superimposed on the eyes of an individual.

FIG. 14A shows a contact lens with an aperture widening zone accordingto one embodiment. FIG. 14B shows a scleral ring with an aperturewidening zone according to one embodiment.

FIGS. 15A-D show various embodiments of a contact lens with differentaperture widening zones having an incremental thickness.

FIGS. 16A-D show various embodiments of a scleral ring with differentaperture widening zones having an incremental thickness.

FIGS. 17A-F show various embodiments of a contact lens with differentaperture widening zones having increased surface friction.

FIGS. 18-19 show a comparison between the eyes of an individual with andwithout a prosthesis having an aperture widening zone. FIG. 18 shows theindividual's natural eyes and FIG. 19 shows the same individual wearinga prosthesis having an aperture widening zone.

FIGS. 20-21 show a comparison between the eye of an individual with andwithout a prosthesis having an aperture widening zone. FIG. 20 shows theindividual's natural eye.

FIGS. 22A-B show a comparison between an individual's left eye with andwithout a prosthesis having an aperture widening zone. FIG. 22A showsthe individual's natural left eye and FIG. 22B shows the individualwearing a prosthesis having an aperture widening zone in the left eye.

FIG. 23 shows a comparison between the right and left eye of anindividual. The individual is wearing a prosthesis having an aperturewidening zone on their right eye and is not wearing a prosthesis havingan aperture widening zone on their left eye.

FIGS. 24A-B show a comparison between the eyes of an individual with andwithout a prosthesis having an aperture widening zone. FIG. 24A showsthe individual's natural eyes and FIG. 24B shows the same individualwearing a prosthesis having an aperture widening zone.

FIGS. 25A-C show the surface profiles for prostheses according tovarious embodiments.

FIG. 26 is a graph illustrating the thickness across prosthesesaccording to various embodiments.

FIGS. 27A-E show the surface profiles for prostheses according tovarious embodiments.

FIG. 28 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 29 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 30 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 31 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 32 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 33 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 34 shows a perspective view of a prosthesis according to oneembodiment.

FIG. 35 shows an aerial view of a prosthesis according to oneembodiment.

FIG. 36 shows an aerial view of a prosthesis according to oneembodiment.

FIG. 37 shows an aerial view of a prosthesis according to oneembodiment.

FIG. 38 shows an aerial view of a prosthesis according to oneembodiment.

FIGS. 39A-E illustrate the surface profile of a contact lens 3900according to one embodiment. FIG. 39A shows an aerial view of thecontact lens. FIG. 39B shows a side view of the contact lens. FIG. 39Cshows a cross-sectional view of the contact lens along its central axis.FIG. 39D shows the convex surface of the contact lens. FIG. 39E showsthe concave surface of the contact lens.

FIG. 40 shows a prosthesis according to one embodiment superimposed onan eye.

FIG. 41 shows a prosthesis according to one embodiment superimposed onan eye.

FIG. 42 shows a prosthesis according to one embodiment superimposed onan eye.

FIG. 43 shows a prosthesis according to one embodiment superimposed onan eye.

FIG. 44 shows a hybrid contact lens according to one embodiment.

FIG. 45 shows a hybrid contact lens according to one embodiment.

FIG. 46 shows a hybrid contact lens according to one embodiment.

FIG. 47 shows a reverse hybrid contact lens according to one embodiment.

FIG. 48 shows an example of a scale used for fitting a prosthesis havingan aperture widening zone.

FIG. 49 shows a scleral ring with an aperture widening zone having anincremental thickness according to one embodiment.

FIG. 50 shows a scleral ring with an aperture widening zone having anincremental thickness according to one embodiment.

FIG. 51 shows a contact lens with an aperture widening zone having anincremental thickness according to one embodiment.

FIG. 52 shows a contact lens with an aperture widening zone having anincremental thickness according to one embodiment.

FIGS. 53A-C show various exemplary embodiments of scleral rings withaperture widening zones having a plurality of bands of incrementalthickness. FIGS. 53D and 53E show various exemplary embodiments ofcontact lenses with aperture widening zones having a plurality of bandsof incremental thickness

FIGS. 54-56 show a comparison of an individual's eyes with and without aprosthesis having an aperture widening zone. FIG. 54 shows theindividual's natural eyes and FIG. 55 shows the same individual wearinga prosthesis having an aperture widening zone. FIG. 56 is a side by sidecomparison of FIGS. 54 and 55.

FIG. 57 is a graph illustrating the outer slope, inner slope andthickness of a prosthesis according to one embodiment.

FIG. 58 is a graph illustrating the outer slope, inner slope andthickness of a prosthesis according to one embodiment.

FIG. 59 is a graph illustrating the outer slope, inner slope andthickness of a prosthesis according to one embodiment.

FIG. 60 is a graph illustrating the outer slope, inner slope andthickness of a prosthesis according to one embodiment.

FIG. 61 illustrates the dimensions and fit to the eye of acorneo-scleral contact lens prosthesis according to one embodimentcompared to the structure of an eye.

FIG. 62 illustrates the dimensions and fit to the eye of a scleral ringprosthesis according to one embodiment compared to the structure of aneye.

FIG. 63A illustrates how to measure the vertical dimension of anaperture widening zone on a prosthesis with an outer edge in the shapeof a circle. FIGS. 63B and 63C illustrate how to measure the verticaldimension of an aperture widening zone on a prosthesis with an outeredge in the shape of a triangle.

FIGS. 64A-C illustrate various orientations of a prosthesis having anaperture widening zone with an outer edge having an oval shape. FIG. 64Aillustrates an orientation having the minimum vertical dimension. FIGS.64B and 64C illustrate orientations not having the minimum verticaldimension.

FIGS. 65A and 65B illustrate how to measure the minimum verticaldimension of an aperture widening zone on a prosthesis with outer edgesin the shape two partial rings.

FIGS. 66A-D illustrate how to measure the minimum vertical dimension ofan aperture widening zone on a prosthesis having a plurality of isolatedareas.

FIG. 67 shows an aerial view of a scleral ring having finger likemembers according to one embodiment.

FIG. 68 shows an aerial view of a contact lens having finger likemembers according to one embodiment.

FIG. 69 shows a side view of a prosthesis having finger like membersaccording to one embodiment.

FIGS. 70A and 70B show a comparison between a set of youthful lookingeyes (FIG. 70A) and a set of eyes having one eye that droops (FIG. 70B).

FIGS. 71A and 71B show a comparison between a set of youthful lookingeyes (FIG. 71A) and a set of aging eyes (FIG. 71B).

FIG. 72 shows the set of eyes in FIG. 70B with a prosthesis having anaperture widening zone according to an embodiment placed on the droopyeye.

FIG. 73 shows the set of eyes in FIG. 71B with a set of prostheseshaving aperture widening zones according to an embodiment placed on theset of eyes.

FIG. 74 shows the set of eyes in FIG. 71B with a set of prostheseshaving aperture widening zones and color enhancing regions according toan embodiment placed on the set of eyes.

FIG. 75 shows the set of eyes in FIG. 71B with a set of prostheseshaving aperture widening zones and color enhancing regions according toan embodiment placed on the set of eyes.

FIGS. 76A-76C show prostheses having color enhancing regions accordingto some embodiments.

DETAILED DESCRIPTION

This specification discloses one or more embodiments that incorporatethe features of this invention. The disclosed embodiment(s) merelyexemplify the invention. The scope of the invention is not limited tothe disclosed embodiment(s). Multiple inventions may be described. Theinvention is defined by the claims appended hereto.

The embodiment(s) described, and references in the specification to “oneembodiment”. “an embodiment”, “an example embodiment”, etc., indicatethat the embodiment(s) described may include a particular feature,structure, or characteristic, but every embodiment may not necessarilyinclude the particular feature, structure, or characteristic. Moreover,such phrases are not necessarily referring to the same embodiment.Further, when a particular feature, structure, or characteristic isdescribed in connection with an embodiment, it is understood that it iswithin the knowledge of one skilled in the art to implement suchfeature, structure, or characteristic in connection with otherembodiments whether or not explicitly described.

It is known that the aperture of the human eye (i.e., largest verticaldistance between an individual's upper lid and lower lid) reduces inoverall diameter by 1.5 mm or more as one matures from that of a childto that of an adult of the age of 40 and even more as one matures tothat of a senior of 60 years or older. This reduction in diameter can befixed surgically through a procedure called blepharoplasty. Presentlythere are approximately 200,000-300,000 blepharoplasty operationsperformed per year in the United States at the cost of approximately$2,500 per upper lids surgery and $3,500 per lower lids surgery. Inaddition to a reduction in aperture size due to old age, someindividuals suffer from blepharoptosis, also referred to as ptosis,which is defined as an abnormal low-lying upper eyelid margin within theeye in primary gaze. The reduction in aperture size can affect anindividual's vision. While a reduction of aperture size can affect thevision of some individuals, some individuals may desire a larger eyeaperture for cosmetic purposes, either in combination with a desire toimprove their vision or not.

Traditional corneo-scleral contact lenses (soft contact lenses or hybridcontact lenses) that fit on the cornea of one's eye (do not vault thecornea) and extend over the limbus and bulbar conjunctiva thus coveringpart of the sclera are not being used for correcting ptosis and/or thewidening of the wearer's palpebral fissure. This is due to theirgeometrical design. Also corneal contact lenses (rigid or soft) that fitonly the cornea and do not extend past the limbus are not used forcorrecting ptosis and/or the widening of the wearer's palpebral fissuredue to geometrical design and overall diameter. Scleral contact lensesare hard/rigid and have been designed in the past to fit snugly againstthe sclera of the wearer's eye, “vault the cornea” and have a very thickedge design such to lift the upper lid of the wearer's eye havingptosis. While scleral contact lenses have existed in the past that willlift the upper lid of the wearer's eye these hard/rigid sclera contactlenses are highly uncomfortable, cause very red eyes and irritate theeye lid margin thus presenting severe limitations for the wearer. Forthese reasons the commercial success of scleral contact lenses tocorrect for ptosis has been a major failure.

Color enhancing soft contact lenses have been developed and have metwith significant commercial success. These color enhancing soft contactlenses can enhance the color of the wearer's eyes. Certain soft contactlenses comprise a colored ring to make the eye of a wearer look largerwhen these soft contact lenses are worn. While colored soft contactlenses having a color ring or band have been used to increase theperception that the eye of the wearer is larger, no soft contact lenshas been developed that both increases the perception that the eye ofthe wearer is larger and also physically widens the palpebral fissure ofthe eye of the wearer.

Thus there is a need for a non-surgical comfortable means to widen thenatural palpebral fissure of an individual's eye. There is also need fora non-surgical means to both open up the aperture of the natural eyethat is also capable of allowing an individual blink without discomfort.And, in some instances, there is the need to restore some of or all lostvisual field function in the case of ptosis due some degree of aparalysis or loss of function of the upper lid. Moreover, there is aneed for a non-surgical means capable of enhancing the cosmetic look ofan individual's eye(s) (e.g., maintain a youthful look or a more alertlook). The cosmetic enhancement may be achieved by physically wideningthe natural palpebral fissure of an individual's eye (i.e., lifting theupper lid and/or depressing the lower lid) and/or providing theperception that the eye of an individual is larger.

Embodiments of the present application described herein, or elementsthereof, may accomplish one or more of these or other objectives.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface and a concave surface. Theprosthesis has an aperture widening zone located on the convex surface.The prosthesis widens the natural palpebral fissure of the wearer's eyeby at least 1 mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. Theprosthesis is a corneo-scleral contact lens that widens the naturalpalpebral fissure of the wearer's eye by at least 1 mm.

Some embodiments include a prosthesis having a convex surface and aconcave surface. An aperture widening zone is located on the convexsurface. The prosthesis is a scleral ring that widens the naturalpalpebral fissure of the wearer's eye by at least 1 mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. The aperturewidening zone includes at least one surface feature. The prosthesiswidens the natural palpebral fissure of the wearer's eye by at least 1mm.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface, a concave surface, and a peripheraledge. The prosthesis also has an aperture widening zone located on theconvex surface. The aperture widening zone including an outer slope andan inner slope with a maximum change in thickness located in between.The outer slope and the inner slope are different. In some embodimentsthe outer slope is greater than the inner slope. In other embodimentsthe inner slope is greater than the outer slope.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer having a convex surface, a concave surface, and a peripheraledge. The prosthesis also has an aperture widening zone located on theconvex surface. The aperture widening zone including an outer slope andan inner slope with a maximum change in thickness located in between.The outer slope and the inner slope are the same.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface and a concave surface.An aperture widening zone is located on the convex surface. The aperturewidening zone has at least one surface feature. The aperture wideningzone also has a minimum vertical dimension.

Some embodiments include a prosthesis capable of being worn on the eyeof a wearer. The prosthesis has a convex surface, a concave surface, aperipheral edge, and a geometric center. An aperture widening zone islocated on the convex surface. The aperture widening zone has at leastone surface feature. At least a portion of the at least one surfacefeature is located at or outside 5.25 mm from the geometric center ofthe prosthesis.

In some embodiments the prosthesis has an overall diameter of at least13.0 mm. In some embodiments the prosthesis has an overall diameter ofat least 13.5 mm. In some embodiments the prosthesis has an overalldiameter of at least 14.0 mm. In other embodiments the prosthesis has anoverall diameter of at least 14.5 mm. In some embodiments the prosthesishas an overall diameter of at least 15 mm. In some embodiments theprosthesis has an overall diameter of at least 15.5 mm. In some otherembodiments the prosthesis has an overall diameter of at least 16.0 mmor larger.

In some embodiments the prosthesis is a rotationally symmetric lens. Insome embodiments the prosthesis is capable of rotating. In someembodiments the prosthesis is not capable of rotating.

In some embodiments the aperture widening zone depresses a lower eye lidof the wearer by at least 1 mm. In some embodiments the aperturewidening zone elevates an upper eye lid of the wearer by at least 1 mm.

In some embodiments the prosthesis includes a colored accent color. Insome embodiments the colored accent color is around a portion of theprosthesis which fits near or at the limbus, or extends past the limbus(meaning the diameter of the colored portion is larger than the diameterof the limbus to limbus measurement) of the eye when the prosthesis isworn. In some embodiments the colored accent color is a limbal ring,circle ring, or circle lens.

In some embodiments the prosthesis is a multifocal contact lens. In someembodiments the prosthesis is a toric contact lens. In some embodimentsthe prosthesis is a single vision contact lens.

In some embodiments the aperture widening zone comprises an area ofincreased surface friction. In some embodiments the increased surfacefriction is provided by a surface treatment, a coating, a differentmaterial, surface dimples, surface irregularities, or combinationsthereof.

In some embodiments the aperture widening zone also includes an outerslope and an inner slope with a maximum change in thickness located inbetween. In some embodiments the outer slope and inner slope aredifferent. In some embodiments the outer slope is greater than the innerslope. In some embodiments the outer slope has an angle between 3° and45°. In some embodiments the outer slope has an angle between 5° and25°. In some embodiments the inner slope comprises an angle between 1°and 15°.

In some embodiments the aperture widening zone has an incrementalthickness and a maximum change in thickness. In some embodiments themaximum change in thickness is within a range of 25 microns to 1,000microns. In some embodiments the maximum change in thickness is within arange of 100 microns to 500 microns. In some embodiments the maximumchange in thickness is within a range of 75 microns to 400 microns. Insome embodiments the maximum change in thickness is located between 1.0mm and 2.5 mm from an outer edge of the prosthesis. In some embodimentsthe maximum change in thickness is located at or exterior to the corneallimbus of the wearer's eye when the prosthesis is worn on the eye. Byexterior it is meant that the maximum change in thickness diameter whenmeasuring from one point of maximum added thickness thru the geometricalcenter of the prosthesis to an opposing point of maximum added thicknessis larger than when measuring from one point on the limbus of thewearer's eye thru the center of the cornea to an opposing point on thelimbus. In some embodiments, the maximum change in thickness is locatedat least 5.5 mm from the geometrical center of the prosthesis (i.e., atleast one half the diameter of the average human cornea, which is 11-12mm). In some embodiments, the maximum change in thickness is located atleast 6.0 mm from the geometrical center of the prosthesis. In someembodiments, the maximum change in thickness is located at least 6.5 mmfrom the geometrical center of the prosthesis. In some embodiments theincremental thickness is an increase in thickness. In some embodimentsthe incremental thickness is a decrease in thickness.

In some embodiments an outermost part of the aperture widening zone islocated within a range of 3 mm to 8.5 mm from a geometric center of theprosthesis. In some embodiments an outermost part of the aperturewidening zone is located within a range of 5 mm to 7.75 mm from ageometric center of the prosthesis. In some embodiments an innermostpart of the aperture widening zone is located between a peripheral edgeof the prosthesis and 6 mm from a peripheral edge of the prosthesis.

In some embodiments the aperture widening zone has a minimum verticaldimension. In some embodiments a minimum vertical dimension of theaperture widening zone is larger than a maximum vertical diameter of thenatural palpebral fissure of the wearer's eye. In some embodiments aminimum vertical dimension of the aperture widening zone is equal to orgreater than 8.0 mm. In some embodiments a minimum vertical dimension ofthe aperture widening zone is equal to or greater than 8.5 mm. In someembodiments the minimum vertical dimension of the aperture widening zoneis equal to or greater than 9.0 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 9.5 mm. In some embodiments, a minimum vertical dimension of theaperture widening zone is equal to or greater than 10.0 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 10.5 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 11.0 mm. In some embodiments a minimum vertical dimension of theaperture widening zone is equal to or greater than 11.5 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 12.0 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is equal to or greaterthan 12.5 mm. In some embodiments a minimum vertical dimension of theaperture widening zone is equal to or greater than 13.0 mm. In someembodiments a minimum vertical dimension of the aperture widening zoneis equal to or greater than 13.5 mm. In some embodiments a minimumvertical dimension of the aperture widening zone is a vertical distancebetween an uppermost part of the aperture widening zone and a lowermostpart of the aperture widening zone.

In some embodiments the aperture widening zone includes at least onesurface feature. In some embodiments the aperture widening zone has aplurality of surface features.

In some embodiments the prosthesis is a corneo-scleral contact lens. Insome embodiments the prosthesis is a scleral ring. In some embodimentsthe prosthesis also has a peripheral edge, a geometric center, and atleast one surface feature. In some embodiments the at least one surfacefeature or at least a portion of the at least one surface is located ator outside 5.25 mm from the geometric center of the prosthesis. In someembodiments the peripheral edge has a knife edge shape, a rounded shape,a blunt shape, or a semi-rounded shape. In some embodiments theperipheral edge has a thickness between 25 microns and 100 microns.

In some embodiments the prosthesis has a hybrid design. In someembodiments the prosthesis has a homogeneous design.

In some embodiments the aperture widening zone comprises a ring,multiple rings, a partial ring, multiple partial rings, an island,multiple islands, a band, bands, partial bands, a segmented area, ormultiple segmented areas. In some embodiments these partial areas arealigned to ring the prosthesis. In other embodiments these partial areasare not aligned to ring the prosthesis.

In some embodiments the prosthesis can be worn by the wearercontinuously. In some embodiments the prosthesis can be worn by thewearer non-continuously. In some embodiments the prosthesis can be wornby the wearer daily, weekly, or monthly.

In some embodiments the prosthesis is disposable. In some embodimentsthe prosthesis is reusable.

In some embodiments the prosthesis comprises an optical power. In someembodiments the prosthesis does not comprise an optical power.

Some embodiments include a prosthesis having an aperture widening zone.The aperture widening zone has an outer slope, an inner slope, a pointof maximum added thickness delta, and an incremental thickness diameter.The prosthesis also has a peripheral edge, a geometrical center, and anoverall diameter. The overall diameter is measured from a first point onthe peripheral edge to a second point on the opposing peripheral edgethru the geometrical center of the prosthesis and the aperture wideningzone. The overall diameter is 13.0 mm or greater. The outer slope iswithin the range of 5 degrees and 25 degrees. The point of maximum addedthickness delta of the aperture widening zone is 75 microns or greater.The point of maximum added thickness delta of the aperture widening zoneis located between 1 mm and 3 mm from the peripheral edge. Theincremental thickness diameter is 8.5 mm or greater. In someembodiments, the incremental thickness diameter is 10.5 mm or greater.

In some embodiments the prosthesis is free to rotate. In someembodiments the prosthesis is not free to rotate.

In some embodiments the incremental thickness diameter is 1 mm largerthan the vertical measurement of the natural aperture of the wearer'seye. In some embodiments the incremental thickness diameter is at least1 mm larger than the vertical measurement of the natural aperture of thewearer's eye.

In some embodiments the prosthesis is a corneo-scleral lens. In someembodiments the prosthesis is a scleral ring.

In some embodiments the prosthesis has optical power. In someembodiments the prosthesis does not have optical power.

In some embodiments the prosthesis is a single vision contact lens. Insome embodiments the prosthesis is a multifocal contact lens. In someembodiments the prosthesis is a toric contact lens.

In some embodiments the prosthesis includes a hydrogel. In someembodiments the prosthesis includes a silicone hydrogel. In someembodiments the prosthesis includes a homogenous material. In someembodiments the prosthesis includes hybrid materials.

In some embodiments the aperture widening zone begins at or adjacent tothe peripheral edge. In some embodiments the aperture widening zonebegins internal to the peripheral edge.

In some embodiments the point of maximum added thickness delta is 100microns or greater. In some embodiments the point of maximum addedthickness delta is 125 microns or greater. In some embodiments the pointof maximum added thickness delta is 150 microns or greater. In someembodiments the point of maximum added thickness delta is 200 microns orgreater. In some embodiments the point of maximum added thickness deltais 225 microns or greater. In some embodiments the point of maximumadded thickness delta is 250 microns or greater.

In some embodiments the prosthesis is one of: daily wear, disposable,continuous wear, weekly wear, or monthly wear.

In some embodiments the prosthesis is not stabilized.

In some embodiments the aperture widening zone is a round ring. In someembodiments the aperture widening zone is a series of partial segmentsthat make up a ring.

Some embodiments provide for a method of widening the natural palpebralfissure of a wearer's eye by providing a protocol or instructions forwidening the wearer's natural palpebral fissure by at least 1 mm andproviding at least one prosthesis comprising an aperture widening zonelocated on its convex surface. In some embodiments the protocol orinstructions include directions to determine a vertical dimension of thewearer's natural palpebral fissure, and to provide the wearer with aprosthesis having a minimum vertical dimension at least 1 mm greaterthan a maximum vertical dimension of the natural palpebral fissure (sucha determination can be made by, way of example only, actual measurement,photography, visual estimate, or by one of, fitting a trial prosthesis,contact lens of a known diameter, or a prosthesis of a known diameter).

A prosthesis of this patent application in the form of a corneo-scleralcontact lens and a scleral ring has been developed that enhances/widensthe palpebral fissure of a wearer's eye to enhance the cosmeticappearance of the wearer's eye (eyes) and can also be used to providerelief to patients suffering from drooping eyelids and/or ptosis. Byenhancing the appearance of the wearer's eye it is meant that it makesthe eye look more open and/or larger, and/or more alert. The novelprosthesis enhances the cosmetic appearance of the wearer by way ofpushing up (elevating) the upper eyelid and/or also pushing down(depressing) the lower eyelid thus enlarging the wearer's palpebralfissure or aperture. The prosthesis has been shown to open the apertureof a wearer's eye by up to an additional 50% from its normal/natural eyeaperture vertical dimension. Given that the average aperture of anindividual's eye under the age of 40 would have a natural aperturehaving a vertical dimension (between the upper lid margin and the lowerlid margin) of approximately 10.5 mm and that after the age of 40 theaverage dimension from the same points is approximately 9 mm, orapproximately a 15% reduction in aperture size it can be seen that theprosthesis described herein can restore the youthful look the ofwearer's eyes.

The prosthesis comprises one or more, by way of example of: anaugmentation in edge thickness, an internal incremental thickness zone,a regressive thickness zone, or an increased surface friction zone(either one) located at or external to the limbus, thus also external tothe pupillary or optic zone which takes the form on the convex surface,by way of example only, of one or more of; a ring, (rings) band,(bands), partial rings (ringlets), dome (domes), island (islands),segmented region (regions), convex surface roughness/friction near oraround the periphery of the lens and/or within or covering the aperturewidening zone, truncation (truncations), overall thickening of thecontact lens, larger diameter, and steeper base curve. The effect is toopen up the palpebral fissure of the eye of the wearer and thus minimizethe impact of blepharoptosis on visual performance and/or enhance thecosmetic appearance of the patient/wearer. The prosthesis when in theform of a corneo-scleral contact lens can be that of a soft contact lensor hybrid contact lens. When the prosthesis is in the form of a scleralring as opposed to a contact lens the scleral ring comprises a centralopen aperture without optical power. The scleral ring can be made of amaterial found in one of a: hard contact lens, gas perm contact lens,soft contact lens; hybrid contact lens. The incremental thickness region(zone, area) or a regressive thickness region (zone, area), or increasedsurface friction region (zone, area) for the prosthesis (being a contactlens or a scleral ring) can be one of: rotationally symmetric,rotationally asymmetric, elliptical arch like feature, and isolatedislands. The elliptical arch (arches) like feature (features) canresemble the curve of the lid margin of the upper lid and/or the curveof the lid margin of the lower lid. The region of incremental thickness,or regressive thickness, or increased surface friction can be eithercontinuous or discontinuous. The incremental thickness region,regressive thickness region, or increased surface friction can be madeof the same material or different materials. The prosthesis can be wornas one of: continuous wear, daily wear weekly continuous wear, ormonthly continuous wear. The prosthesis can be disposable or reusable.The prosthesis can be removed and reinserted by the wearer.

Aperture of the eye (Palpebral Fissure): Is the area located between aneye's upper lid and the lower lid when the eye lids are open.

Aperture Widening Zone: (Also can be called one or more of anincremental thickness region/zone/area, a regressive thicknessregion/zone/area or an increased surface friction region/zone/area). Isa region, zone, area that provides topography, or surface friction thatraises (elevates) the upper lid and/or depresses (lowers) the lower lidthus widening the aperture of the eye.

Aperture Widening Zone Diameter: Is the dimension of the distance/lengthfrom a point on the peak incremental thickness (i.e., maximum thicknessdelta) of the aperture widening zone measured to the opposite like peakof incremental thickness through the geometrical center of a contactlens or scleral ring. This may also be called the incremental thicknessdiameter. Or, when the aperture widening zone is flat, then it ismeasured from the midpoint of the aperture widening zone to the oppositemidpoint located on the aperture widening zone when measured through thegeometrical center of the contact lens or scleral ring.

Area of incremental thickness: The area located within the region orzone of incremental thickness of the scleral ring or contact lens.Should (by way of example only) the region or zone of incrementalthickness be a plurality of regions or zones the area of incrementalthickness would be referred to as areas of incremental thickness. Itshould be noted that an area of incremental thickness can be formedeither by way of adding thickness to the surface or by removingthickness around the area of incremental thickness (thus by a regressivethickness zone).

Blepharoptosis: also referred to as ptosis, is defined as an abnormallow-lying upper eyelid margin with the eye in primary gaze. The normaladult upper lid lies 1.5 mm below the superior corneal limbus and ishighest just nasal to the pupil. Blepharoptosis can be classified ascongenital, as shown below, or acquired. This differentiation is basedon age. A more comprehensive classification is based on etiology andincludes myogenic, aponeurotic, neurogenic, mechanical, traumatic, andpseudoptotic. The most common cause of congenital ptosis is myogenic dueto the improper development of the levator muscle.

Blepharoplasty is the name of the surgical procedure that provides forlid lifting. Presently there are approximately 200,000-300,000blepharoplasty operations performed per year in the United States at thecost of approximately $2,500 per upper lids surgery and $3,500 per lowerlids surgery. Blepharoplasty is one of the top facial cosmetic surgicalprocedures performed for those over the age of 40. In addition, itshould also be noted that big eyes are perceived to be more attractivethan small eyes in today's global society

Centration of scleral ring or contact lens: As used herein is meant tobe the proper centering of the scleral ring or contact lens so that thewearer's limbus and/or pupil is mostly centered within the open apertureof the scleral ring or in the case of a contact lens the wearer's pupilis mostly centered within the optic zone.

Central Open Aperture: Means a hole or opening devoid of material thatincludes the geometrical center of the prosthesis.

Contact Lens: Is a thin lens designed to fit over the cornea and usuallyworn to correct defects in vision. Contact lenses generally fall intothree major categories: #1) corneal contact lens, #2) Corneo-scleralcontact lens, and #3) Scleral contact lens. The three major categoriescan then be further broken down into sub categories (by way of exampleonly) A) daily wear (meaning only used daily for wearing and taking outwhen sleeping), B) continuous wear (meaning wearing day and night roundthe clock for a limited number of days, and C) disposable contact lenseswhich can be worn either daily or continuously, but are discarded whenthey become dirty or lose certain optical or comfort qualities. (It isimportant to note that the prosthesis being disclosed herein is that ofcategory 12 (corneo-scleral contact lens) therefore when the termcontact lens is used it is meant to be that of a corneo-scleral contactlens).

Corneal contact lens: Corneal lenses are supported exclusively by thecornea, and do not extend past the limbus (the junction between thecornea and the sclera). An example of a corneal contact lens would be ahard rigid contact lens having a diameter no larger than the diameter ofthe wearer's cornea and in most cases smaller than the diameter of thewearer's cornea. Corneal contact lenses can also be soft contact lens.

Corneo-scleral lenses: Corneo-scleral lenses are a type of contact lensused to correct defects in vision. The name refers to the area andresting points of the lens in the eye. Corneo-scleral lenses aresupported by both the cornea and bulbar conjunctiva that is above thesclera, and do extend past the limbus. Examples of corneo-scleralcontact lens would be: soft contact lens and hybrid contact lens. Theselenses have a diameter in excess of the diameter of the wearer's corneaand extend past the wearer's limbal area. They range generally (but notalways) from 12.5 to 15 mm in diameter. The tear reservoir underneath acorneo-scleral lens is very limited compared to full scleral contactlenses that vault the cornea. Corneo-scleral lenses are the most commonused. Corneal-scleral lens may be made of a hydrogel materials, such asbut not limited to, a silicone hydrogel material.

Delta Incremental Thickness, Incremental Thickness Delta, Delta ofIncremental Thickness, and Maximum Change in Thickness: Is thedifference in thickness between a point located within the incrementalthickness region and the normal thickness of the contact lens or scleralring measured at the same point. The maximum delta is the point wherethe thickness differential or maximum delta thickness is the greatest orsaid another way, the point where the maximum change in thickness isfound.

Color Enhancing Region: A region, zone, area, that provides at least acolor different from the rest of a prosthesis. The prosthesis mayinclude a color enhancing region. When the prosthesis is acorneo-scleral contact lens or scleral ring the color enhancing elementcan be located on the outer convex surface or concave surface of thecontact lens or ring, or buried between the inner convex surface and theouter opposing concave surface. The color enhancing region can belocated on or within the corneo-scleral contact lens or scleral ringsuch to cover a portion of the limbal area of the wearer's eye when theprosthesis is being worn. In some embodiments the color enhancing regioncan be located on or within a corneo-scleral contact lens or scleralring so as to cover all of the limbal area of the wearer's eye andextend over the limbal area of the wearer's eye over a portion of thewearer's cornea when the prosthesis is being worn. In some embodimentsthe color enhancing region can be located on or within a corneo-scleralcontact lens or scleral ring such to extend over the limbal area of thewearer's eye and over a portion of the sclera of the wearer's eye whenthe prosthesis is being worn. In some embodiments, the color enhancingregion can be located on or within the corneo-scleral contact lens orscleral ring so as to extend over the limbal area of the wearer's eye,over a portion of the cornea of the wearer's eye and over a portion ofthe sclera of the wearer's eye when the prosthesis is being worn. Thecolor enhancing region can be rotationally symmetric on or within theprosthesis. The color enhancing region can be non-rotationally symmetricon or within the prosthesis. The color enhancing region can be, by wayof example only, a ring, broken ring, zone, series of zones, a uniformcolor, multiple colors, multiple shade of a particular color, an accentcolor. The color enhancing region can cause the perception of thewearer's iris to look larger. The color enhancing region can change thecolor of the wearer's eye. The color enhancing region can make thewearer's eye look larger. The color enhancing region can only slightlyalter the color of the wearer's eye. The color enhancing region cangreatly alter the color of the wearer's eye.

When located on the surface of the contact lens or scleral ring, thecolor enhancing region can be a surface feature. In some embodiments,the entire color enhancing region may provide an increased surfacefriction. In some embodiments, a portion of the color enhancing regionmay provide increased surface friction. The color enhancing element canbe, by way of example only, a limbal ring, a colored ring, a colorenhanced iris area (e.g., tinted iris ring), or an accent color. Thecolor enhancing region can serve to both provide color and also as aneye aperture widening element. In some embodiments, the color enhancingregion can cover all of the limbus of the eye of the wearer and also allof the cornea of the eye of the wearer when the prosthesis is beingworn. The color enhancing region may overlap, in whole or in part, withan aperture widening zone.

Delta Regressive Thickness, Regressive Thickness Delta, Delta ofRegressive Thickness, and Maximum Change in Thickness: Is the differencein thickness between a point located within the regressive thicknessregion compared to a thickness of a near (closely located) area of thecontact lens or scleral ring internal (on the side towards the center ofthe prosthesis). The maximum delta is the point where the thicknessdifferential or maximum delta thickness is the greatest, or said anotherway, the point where the maximum change in thickness is found.

Edge: The edge of the contact lens or scleral ring as used herein is theouter peripheral circumference of the contact lens or in the case of ascleral ring, either the outer peripheral edge or inner peripheral edgeclosest to the open aperture of the scleral ring. The inner edge of ascleral ring (adjacent to the open center aperture) has a similarcontour as that of the outer edge of the scleral ring.

Gas perm contact lens: Is a contact lens comprising a rigid materialthat is permeable to oxygen; such a material is used in gas perm cornealcontact lenses that are of a diameter equal to or less than the diameterof the wearer's cornea or in the central rigid gas permeable region of ahybrid contact lens whereby the material which is central to that of asoft hydrophilic skirt is of a gas permeable material.

Geometrical Center: Geometrical center as used herein is meant to be theabsolute center of a scleral ring or contact lens. In the case of acontact lens it is real; in the case of a scleral ring it is imaginarygiven the central open aperture.

Hybrid Contact Lens or Hybrid Scleral Ring: A hybrid contact lens asused herein is a contact lens or scleral ring comprised of two or morematerials bonded together. An example of this would be like that oftoday's commercially available hybrid contact lens comprising a centralgas permeable material and an outer soft hydrophilic contact lens skirt.

Three additional embodiments discussed herein are: #1) An embodimenttaught herein whereby the outer periphery of the hybrid contact lens isrigid and the center is soft or #2) In the case of a scleral ring, aring that rests over the sclera being of a more rigid (less soft or morerigid) material, however, having affixed to the scleral ring, a softermore pliable material that forms part or all of the incrementalthickness zone that provides the widening effect. This softer morepliable material can be in the form of finger like members that extendaway from the more rigid scleral ring. #3) In the case of a soft contactlens having a member or surface treatment which is not of the samematerial that provides increased surface friction such to raise theupper lid and/or lower the lower lid.

Incremental Thickness: Is that of the increased differential or deltathickness when taking a point on the base scleral ring or contact lensof a normalized convex surface or normalized concave surface andcalculating the differential from that point to that of the same pointon the scleral ring or contact lens taught herein. Said another way;after mathematically normalizing the convex surface curvature of thescleral ring or contact lens, is the additional thickness added over andbeyond the normalized convex surface or normalized concave surface ofthe scleral ring or contact lens. It is important to note for a contactlens the convex surface of the optic zone is not considered in thecalculation of the normalized convex surface and thus excluded, as theoptic zone may have a different convex curvature due to the specificoptical power of the contact lens. The maximum incremental thickness isthe peak thickness delta or the maximum change in thickness. It isimportant to note that incremental thickness can be created by beingsurrounded or adjacent to a regressive thickness region.

Incremental Thickness Diameter: The incremental thickness diameter isthe distance along the vertical axis from a point of maximum deltathickness or maximum change in thickness proceeding through thegeometrical center of the prosthesis in a straight line to that of apoint of maximum delta thickness or maximum change in thickness locatedon the opposite side from the previous point of maximum delta thickness.

Incremental Thickness Region/Zone/Area: (also is referred to as an“Aperture Widening Zone”) is a phrase coined for the purposes of thispatent application. Incremental thickness zone is the additionalthickness of a zone, region, area that is added over and beyond thenormalized convex surface or normalized concave surface of the contactlens or scleral ring. The incremental thickness zone can also be made upof a plurality of zones or regions of incremental thickness and can befurther broken into an area or areas of incremental thickness. In most,but not all cases, the incremental thickness zone or region provides nouseful vision correction for the wearer. The incremental thickness zoneis also called the aperture widening zone. The purpose of theincremental thickness region or zone is that of providing a forceagainst the upper lid (lids) to lift (elevate) and/or the lower lid tolower (depress) such to widen the eye's palpebral fissure (aperture) ofthe wearer.

Incremental Thickness Zone Width: Is the width measurement on the convexsurface of the scleral ring or contact lens where the incrementalthickness zone begins and ends. This is the width of the incrementalthickness zone usually measured from the portion closest to the outeredge of the prosthesis to the portion closest to that of the geometricalcenter of the prosthesis

Inner Slope: The “inner” slope is the slope of the aperture wideningzone between the point of maximum thickness delta and where the aperturewidening zone ends closest to the geometrical center of the prosthesis.

Junction: Junction as used herein is meant to be the location of aconventional hybrid contact lens where the gas permeable centralregion's outer peripheral edge meets the inner peripheral edge of theouter soft skirt or in the case of a hybrid scleral ring or a reversehybrid lens is the location of where the two different materials meet.

Limbus: The marginal region of the cornea of the eye by which it isadjacent with the sclera. The average diameter of the cornea isapproximately 11-12 mm and normally recognized to be approximately 11.5mm on average.

Minimum Vertical Dimension: Is one way to measure and/or quantifystructural features of a prosthesis with an aperture widening zone.Minimum vertical dimension is a parameter used to quantify some, but notnecessarily all, embodiments described here. “Vertical dimension” is thevertical distance between the highest part of an aperture widening zonenear the top of the prosthesis, and the lowest part of an aperturewidening zone near the bottom of the prosthesis. In other words, the“vertical dimension” defines the vertical distance between the uppermostpart of the prosthesis that pushes the upper eyelid up, and thelowermost part of the prosthesis that pushes the lower eyelid down.Where the aperture widening zone starts at the edge of the prosthesis,the “vertical dimension” of the aperture widening zone corresponds tothe vertical size (overall diameter) of the prosthesis. If the highestand lowest parts do not lie on the same vertical axis, then the“vertical dimension” is the distance between a projection of the highestand lowest points onto a vertical axis. If the aperture widening zone isnot rotationally symmetric, the vertical distance may change as theprosthesis is rotated. The “minimum vertical dimension” is the verticaldimension that corresponds to the rotational position(s) of theprosthesis that has the smallest vertical dimension. Pressure from theeye lids will, in many cases, tend to rotate the prosthesis into thisrotational position.

Multifocal Contact Lens: Is a contact lens comprised of two or moreoptical power regions. Such a contact lens is used to correct presbyopiaas well as at a minimum the wearer's distance vision. Some multifocalcontact lenses will correct distance, intermediate and near vision ofthe wearer.

Natural Palpebral Fissure (Natural Aperture): The space between themargins of the eyelids—called also rima palpebrarum. The naturalpalpebral fissure is the space or area of the palpebral fissure when notwearing a contact lens, when the eye or eyes are relaxed and while theindividual is expressionless and not squinting, smiling or frowning etc.

Normalized Front Convex Surface: Is meant to mean a front convex surfacewithout any incremental thickness added to that of a normal front convexsurface of a contact lens or scleral ring. The normal front convexsurface can be that of a non-spherical convex curvature or a sphericalconvex curvature. In most, but not all, cases the normalized frontsurface is that of a spherical curvature. Said another way thenormalized front convex curvature equals the convex curvature minus theincremental thickness added. When normalizing the convex surface of acontact lens the normalized surface does not take into account theconvex surface of the optic zone as the optic zone may have a differentcurvature influenced by the optical power of the contact lens.

Normalized Back Concave Surface: Is meant to mean a back concave surfacewithout any incremental thickness added to that of a normal back concavesurface of a contact lens or scleral ring. The normal back concavesurface can be that of a non-spherical convex curvature or a sphericalconvex curvature. The normalized back concave surface can be that of anaspheric surface. In most, but not all, cases the normalized backconcave surface is that of a spherical curvature. Said another way thenormalized back concave curvature equals the concave curvature minus theincremental thickness added.

Optic Zone: Is the central zone of the contact lens that comprisesoptical power. The optic zone is of a fixed size and in a fixed locationwithin the contact lens. In the disclosure contained herein the termoptic zone and optical zone are meant to mean the same. Generally theoptic zone of soft contact lenses ranges between 7 mm to 9 mm indiameter. The optic zone diameter is generally larger than the pupillaryzone diameter to prevent glare and light scatter when the pupil dilatesat night. The scleral ring does not have an optic zone, but rather anopen aperture.

Overall Outer Diameter: The diameter measured from the outer edge of theprosthesis across the prosthesis through the geometrical center to theopposing outer edge.

Outer Slope: The “outer” slope is the slope of the aperture wideningzone between the point of maximum thickness delta and where the aperturewidening zone ends closest to the outer edge of the prosthesis.

Overall Thickness: The thickness when measured at a point on the concavesurface of the contact lens or scleral ring to a point on the outsideconvex surface at the same point relative to one another.

Peak Thickness Delta (Maximum Thickness Delta): Is the maximumincremental thickness (added) or the maximum regressive thickness(reduced). Said another way is the maximum change in thickness.

Prosthesis: A device worn by a wearer that provides a benefit for thewearer. In the case of the disclosure disclosed herein the benefit canbe that of a cosmetic benefit or a vision benefit.

Ptosis: A drooping of the upper eyelid caused by way of example only:from paralysis of the oculomotor nerve. Ptosis refers to abnormaldrooping of the upper eyelid which can affect one or both the eyes. Itmay be constant or intermittent in nature. Ptosis can be congenital, ifpresent since birth, or it may be acquired when it develops later inlife. Usually ptosis occurs as an isolated disorder but may also beassociated with various other conditions. Ptosis may afflict bothchildren and the adult population. Incidence of ptosis has been reportedto be 0.18% in children, but occurs more frequently in older adults,probably due to the aging factor, and may affect up to 1% of thepopulation or more. Both men and women are equally susceptible toptosis.

The most common feature of ptosis is drooping of the upper eyelid of theaffected eye. Depending on the severity of drooping, it is categorizedinto: minimal (1-2 mm), moderate (3-4 mm) and severe (>4 mm).Individuals with ptosis may complain of increased tearing and blurredvision. Patients with significant ptosis may need to lift the eyelidwith a finger, or raise their eyebrows for normal straight vision andthis may lead to tension headaches and eyestrain.

Ptosis occurs when the muscles that raise the eyelid (levator andMuller's muscles) are not strong enough to do so properly. It can affectone eye or both eyes and is more common in the elderly, as muscles inthe eyelids may begin to deteriorate. Ptosis usually results due tofailure of eyelid muscles to function properly. This may occur due tolocalized damage to eyelid muscles or damage to nerves supplying theeyelid muscles. It may also occur as a normal aging process. Individualswith diseases like Myasthenia gravis, Diabetes mellitus, stroke, Homer'ssyndrome and brain tumor are at increased risk of acquiring ptosis. Infact myasthenia gravis, which is a neuromuscular disorder, is one of thecommon causes of acquired ptosis. It has also been reported that longterm wearers of contact lenses may develop ptosis and also those who useBotox for cosmetic treatment of appearance. If left untreated,especially in children, ptosis may lead to a complication called ‘LazyEye’ where the child cannot see properly with one of his or her eyes.This condition can be reversed if treated properly. There may beemotional disturbances in children due to visual defect and physicaldisfigurement.

Regular monitoring of the condition is required in cases of mild ptosis,where no visual impairment is present. However, significant congenitalptosis may warrant surgical intervention which includes expertise of aneye specialist and a plastic surgeon. Surgical modalities includecorrection of eyelid muscles and procedures like Levator resection,Muller muscle resection or Frontalis sling operations are generallyperformed. Non-surgical modalities like use of Crunch glasses or specialScleral contact lenses are also popular nowadays. FIG. 1 shows anindividual with congenital ptosis on the left eye.

FIG. 2 illustrates a visual field that shows the functional blockage dueto a ptotic lid. Ptosis can affect the visual field of the wearer's eyethus limiting the area of functional vision. If the ptosis is of theupper lid and whereby the upper lid covers a portion of the pupil theindividual having the ptosis will lose the ability to see in a portionof his or her superior visual field. FIGS. 3-7 show four individualsafflicted with ptosis. Ptosis can afflict all ages with the highestincidence in those over the age of 40.

Pupillary Zone: As used herein is the zone of a contact lens when wornby a wearer, whereby the wearer's pupil would be in opticalcommunication with (or said another way where the pupil of the wearer'seye would receive light through). The pupillary zone is of a larger areaat night or dim illumination when the pupil is dilated and of a smallerarea in higher levels of ambient light. The pupillary zone of theprosthesis described herein generally ranges from approximately 6 mm indiameter to 8 mm in diameter (or a radius of 3 mm to 4 mm from thegeometrical center of the contact lens) in order to cover the pupil whenthe pupil dilates due to a low level of ambient light. The pupillaryzone is generally smaller than the contact lens optic zone, or opticalzone. The pupillary zone is located within the scleral ring central openaperture.

Piggy Back: The term “piggyback” or piggybacking is that of: of asmaller, rigid contact lens on the surface of a larger, soft contactlens. These techniques give the vision corrections benefits of a rigidlens and the comfort benefits of a soft lens. The term can also apply totwo or more soft contact lenses being worn simultaneously.

Region: The terms region, zone, area all have the same meaning in thisdisclosure.

Regressive Thickness: Is a reduction of thickness.

Regressive Thickness Diameter: The incremental thickness diameter is thedistance along the vertical axis from a point of maximum delta thicknessproceeding through the geometrical center of the prosthesis in astraight line to that of a point of maximum delta thickness located onthe opposite side from the previous point of maximum delta thickness.

Regressive thickness region: (Also referred to as an “Aperture WideningZone”) is a region whereby the normalized thickness of the prosthesis isreduced such to form by way of example only, a “valley” like area,region, zone of topography on the convex surface of the prosthesis or a“partial” valley like area, region, zone whereby one side increases inthickness and the other side maintains the same thickness or decreasesfurther in thickness. A regressive thickness region generally (but notalways) results in an incremental thickness region.

Regressive Thickness Zone Width: Is the width measurement on the convexsurface of the scleral ring or contact lens where the regressivethickness zone begins and ends. It is generally (but not always)measured from where it starts closest to the outer edge of theprosthesis to where it ends on the side closer to the geometrical centerof the prosthesis.

Reverse Hybrid Contact Lens: This is a hybrid prosthesis whereby theouter skirt is made of a rigid material and the center zone is made of asoft lens material.

Rigid Center: Rigid center is meant to be the area of a contact lens;conventional gas perm or hybrid gas perm being made of a rigid material.

Ring: The term ring as used herein can be that of a continuous ring or adiscontinuous ring. Thus a ring of incremental thickness can be one thatis a continuous ring or a broken discontinuous ring. A ring can also becalled one of a band (bands), zone (zones), island (islands), region(regions), and segment (segments) that rings the prosthesis eithercontinuously or discontinuously.

Sclera: The whitish covering of the eye which joins the cornea at thelimbus and is covered in certain regions of the eye by the bulbarconjuctiva.

Scleral Ring Eye Enhancer (scleral ring): A prosthesis device which fitsover the sclera of the eye of a wearer, has a topography (aperturewidening zone) located on its convex outer surface that provides forwidening of the palpebral fissure of the wearer and comprises an opencentral aperture such to not interfere with the line of sight of thewearer. A scleral ring can comprise one material (homogenous) ormultiple materials in the case of a hybrid scleral ring. A hybridscleral ring can comprise finger like members that lift the upper lidand/or lower the lower lid. The scleral ring does not comprise opticalpower. In most, but not all cases, the scleral ring does not cover partsof the cornea. However, in some embodiments the scleral ring will coverthe limbus and a very limited peripheral region of the cornea.

Scleral Contact lens: A scleral lens is a specially designedlarge-diameter “rigid” contact lens that vaults the cornea (meaning itdoes not rest on the cornea). They can range from 14 mm to over 20 mm indiameter. They are called “scleral” lenses because they completely coverand vault the cornea (the clear dome of tissue that covers the coloredpart of the eye) and extend onto the sclera (the white part of the eyethat forms the outer wall of the eye). Scleral lenses are supportedexclusively by the sclera, and completely vault the cornea and thelimbus. Scleral lens fit very tightly on the sclera of the wearer's eye.

Silicone Hydrogel: Is a material used for soft contact lenses. In 1998,silicone hydrogels became available. Silicone hydrogels have both theextremely high oxygen permeability of silicone and the comfort andclinical performance of the conventional hydrogels. Because siliconeallows more oxygen permeability than water, the oxygen permeability ofsilicone hydrogels is not tied to the water content of the lens. Lenseshave now been developed with so much oxygen permeability that they areapproved for overnight wear (extended wear). Lenses approved for dailywear are also available in silicone hydrogel material.

Disadvantages of silicone hydrogels are that they are slightly stifferand the lens surface can be hydrophobic and less “wet-able.” Thesefactors can influence the comfort of the lens. New manufacturingtechniques and changes to multipurpose solutions have minimized theseeffects. A surface modification processes called plasma coating altersthe hydrophobic nature of the lens surface. Another techniqueincorporates internal rewetting agents to make the lens surfacehydrophilic. A third process uses longer backbone polymer chains thatresult in less cross linking and increased wetting without surfacealterations or additive agents.

Single Vision Contact Lens: A contact lens comprising a single opticalpower. The optical power can be to correct one or more of: hyperopia,myopia, and astigmatism.

Slide Resistance: The resistance imparted between the lid (lids) and thecontact lens as the lid (lids) blink and move across the contact lens orscleral ring.

Slope: Is the curvature or topography of an external surface. Morespecifically the slope in this disclosure is characterized as the degreeof incline or decline of the aperture widening zone, region or area. Theslope is characterized by the outer slope and the inner slope.

Soft skirt: Soft skirt is the outer circular zone of soft hydrophilicmaterial found located on a hybrid contact lens or scleral ring.

Soft Contact Lens: While rigid lenses have been around for about 120years, soft lenses are a much more recent development. The principalbreakthrough in soft lenses made by Otto Wichterle led to the launch ofthe first soft hydrogel lenses in some countries in the 1960s and theapproval of the “Soflens” daily material (polymacon) by the UnitedStates FDA in 1971. Soft contact lenses are immediately comfortable,while rigid contact lenses require a period of adaptation before fullcomfort is achieved. The biggest improvements to soft lens polymers havebeen increasing oxygen permeability, lens wettability, and overallcomfort.

Stabilization zone: A region, zone, area that stabilizes the prosthesissuch as by way of example only; co-axial stabilization zones,truncation, prism ballast, slab off weighted. A stabilization zone willsubstantially reduce or stop rotation of the prosthesis when in the eyeupon lid blinks. The stabilization zone generally touches the lidmargins to prevent the lens from rotating. Stabilization zones orfeatures can cause a reduction in oxygen transmission by a soft contactlens to the wearer's cornea.

Surface Feature: A feature located on the surface of the prosthesis thatis different from the rest of the prosthesis. This feature can be, byway of example only, an increased/decreased thickness, increased surfacefriction, a region made of a different material, dimples, bumps,surfaces irregularities, any change in surface topography, and anycombination thereof. A surface feature can include an aperture wideningzone. A surface feature can be located within an aperture widening zone.A surface feature can include or can be an area of increased surfacefriction. A surface feature can be located within an area of increasesurface friction. A surface feature can be of a rotationally symmetricdesign. A surface feature can be of a ringed design. A surface featurecan be of a broken ring design. A surface feature can be of anon-rotationally symmetric design. A surface feature can be created by,for example, but not limited to: molding, stamping, laser etching,chemical etching, laser treatment, chemical treatment, deposition, gasexposure, printing, altering the exposed external surface, the additionof a different material, the addition of the same material, modifyingthe exposed convex surface material. In some embodiments, a surfacefeature may include a raised surface relative to the normalized frontconvex surface of a prosthesis. In some embodiments, the surface featuremay have a raised height of 1 angstrom or more. In some embodiments, asurface feature may have no raised surface relative to the normalizedfront convex surface of a prosthesis (i.e., may be flat relative to thenormalized front convex surface). In other words, the area of increasedsurface friction may take on the normal curvature of the convex surfaceof the prosthesis. A surface feature can comprise an irregular surface.

Surface Friction or Increased Surface Friction: Means a surface area,zone, region of the convex surface of the prosthesis which provides foran increased surface friction when contacted by the eye lids of thewearer of the prosthesis. This area on the convex surface of theprosthesis can be located on the aperture widening zone. This area orzone can be provided on the surface of the zone or region of incrementalthickness or in place of the zone or region of incremental thickness. Anincreased surface friction region, zone, area can be flat or raised.

Small Eye Aperture: As used herein generally is an eye having an eyeaperture (palpebral fissure) having a natural vertical dimension of lessthan 9.5 mm when relaxed (no smiling or squinting) and looking straightahead at far. Many (but not all) Asian eye apertures (palpebralfissures) fall within this category.

Thickness Region or Zone: The region or zone of the contact lens wherethe incremental thickness is added to that of a base contact lens. Thisregion or zone is where thickness is added to the convex externalsurface. It can also be referred to as the incremental thickness zone.

Thickness differential: Is a region, zone, area of the prosthesiswhereby a first point is thinner than a second point which is adjacentto the first point. In most cases (not all) this thickness differentialis gradual and not a step function resulting in a discontinuity.Thickness differential can be found on the prosthesis in the region ofincremental thickness, or a regressive thickness region.

Thickness Slope: The measured thickness per traveled mm along ahorizontal axis of a surface topography having an incline or decline.The thickness slope can be calculated using incremental thickness orregressive thickness, and also by way of the overall thickness. Thethickness slope can be located at the outer thickness slope region orthe inner thickness slope region both of which are associated with theaperture widening zone.

Toric Contact Lens: Is a contact lens that is comprised of a toricregion or zone that corrects for an astigmatic error of the wearer. Atoric lens of this type can be a cylindrical corrective power or asphero-cylindrical optical power.

Vertical Dimension: Is the distance between the highest and lowestpoints of the aperture widening zone projected onto a vertical axis. Ifthe aperture widening zone is not symmetrical in nature the verticaldimension may vary as the lens rotates, i.e. the vertical dimension is afunction of the rotational position of the lens.

FIGS. 8-11 are examples of eyes that should be excluded from the patientpopulation being fit with the contact lens being taught herein. Itshould be noted that the upper lids of the individuals in FIGS. 8-11 donot come within 2 mm of the upper edge of the pupil or the lower liddoes not come within 2 mm of the lower edge of the pupil.

As discussed above scleral hard/rigid contact lenses designed to liftthe upper lid have been a major failure in the market place due to thesignificant discomfort associated with such a lens when the wearernormally blinks his or her lids. In addition, the cosmetics of the eyewhen wearing such a scleral contact lens is not pleasing for the wearer.For all practical purposes such sclera contact lenses designed forcorrecting ptosis have largely ceased being commercial since the 1980s.Rigid corneal contact lenses that fit only on the cornea are not capableof lifting the lid of a wearer as the lid will push the contact lens offcenter.

Conventional corneo-scleral contact lenses (those most popular in theworld today) (prior to the corneo-scleral contact lenses taught herein)due to their geometrical design have not been capable of lifting thelids or opening the palpebral fissures of a plurality of corneo-scleralcontact lens wearers. Corneo-scleral contact lenses provide a pluralityof different optical corrections. The use of a the phrase a “pluralityof different optical corrections or prescriptions” is meant to be theoptical power or prescription of wearers of corneo-scleral contactlenses being of piano (no optical power) and also mostly all knownoptical prescriptions or optical powers provided by contact lenses.

Thus there is an unmet need for a prosthesis in the form of acorneo-scleral contact lens (soft contact lens and/or hybrid contactlens) capable of being designed to provide mostly any and all knownoptical powers including plano, a high level of comfort, goodcentration, and excellent nourishment that will lift the upper lid (inthe case of a ptosis) and/or lower the lower lid of the wearer thuswidening the wearer's palpebral fissure (or fissures/apertures whenwearing two such contact lenses; one for the right eye and one for theleft eye).

In addition, there is a pressing need for a prosthesis which widens thepalpebral fissure (aperture) of the eye for a “non-wearer” of contactlenses. Such a prosthesis is described herein as another embodiment inthe form of a scleral ring. A scleral ring is not intended to be acontact lens. A scleral ring does not comprise an optic zone or anyoptical power. The central region of a scleral ring is that of a centralopen aperture. However, the scleral ring as taught herein comprises anaperture widening zone that widens the palpebral fissure or eye apertureof the wearer.

It should be pointed out that when the term “contact lens” is usedherein, unless mentioned as that of one of a scleral contact lens, a gasperm corneal contact lens, or a hard corneal contact lens, is meant tobe that of a corneo-scleral contact lens. The contact lens which isdisclosed herein is that of a corneo-scleral contact lens. Thereforewhen reading this disclosure the term “contact lens” should always beinterpreted to be that of a corneo-scleral contact lens with theexception noted within this paragraph. The term scleral ring should beunderstood to have the meaning as defined in the definitions which arecontained herein. A sclera ring can be made of soft lens materials byway of example only, hydrogel, silicone hydrogel or gas perm materialsor non gas perm/standard hard lens materials. Such soft, gas perm or nongas perm materials are well known in the art.

The embodiments disclosed herein teach a prosthesis in the form of acorneo-scleral contact lens and in the form of a scleral ring. Thecorneo-scleral contact lens has a region or zone of a minimum of 25 ormore microns of incremental thickness located anywhere within a regionoutside of a point 3.0 mm from the geometrical center of the contactlens, whereby the corneo-scleral contact lens thru its optic zoneprovides the appropriate optical power to largely correct the wearer'suncorrected refractive error and whereby the incremental thickness isthe thickness delta measured at the same point compared to that of thesame manufacturer's conventional contact lens for providing the sameoptical power correction and of the same type and whereby the region ofincremental thickness causes a widening of the palpebral fissure of thewearer's eye. The corneo-scleral contact lens can be by way of exampleonly, a soft contact lens or a hybrid contact lens. The corneo-scleralcontact lens can be of an optical design of any one or more of a singlevision, multifocal, toric, and astigmatic contact lens. The soft contactlens can be that of a continuous wear, daily wear, planned replacementor disposable. The corneo-scleral contact lens can have a colored,tinted iris ring, limbal ring or circular band located appropriatelyremoved from the optic zone of the contact lens to further accentuate awidening of the palpebral fissure of the wearer. A portion of thiscolored, tinted ring or band can be located approximately adjacent butover that of the limbus of the eye of the wearer and can extend beyondthe limbus of the wearer. Meaning the outer diameter of the coloredportion to colored portion can be larger than the diameter of the limbusto limbus measurement.

The scleral ring is that of a ring which generally, but not always, hasits outer peripheral edge located under the upper and lower lids whenthe eye is opened normally and has its inner peripheral edge locatedoutside of the wearer's pupil diameter (when naturally dilated fordarkness) such to not interfere with the line of sight of the wearer.The inner edge of a scleral ring (adjacent to the open center aperture)has a similar contour as that of the outer peripheral edge of thescleral ring. This helps to prevent discomfort for the wearer when he orshe blinks. The scleral ring has an open central aperture which allowsfor the wearer's line of sight to be uninhibited. The scleral ring canbe comprised of any of the various contact lens materials; hard, gasperm, soft, hybrid. The scleral ring can comprise an aperture wideningzone or region of incremental thickness, regressive thickness and/or anarea of increased surface friction. An increased surface friction zonecan be flat or raised on the convex surface of the prosthesis. Theregion or zone of incremental thickness can be, by way of example only,made of one material (which is that of the base material of the ring) orof multiple materials such that a more pliable softer material isaffixed to the more rigid, less pliable soft material of the mainscleral ring. In most, but not all cases, when speaking of a hybridscleral ring the more pliable material (less rigid) provides the upperlid lift and lower lid depression.

A hybrid scleral ring in some, but not all, embodiments can comprisefinger like members that lift the upper lid and/or lower the lower lid.The scleral ring does not comprise optical power. The mechanism ofaction is that the upper and lower lids provide a force when closing orclosed that overcomes the normal force needed to fold or bend the fingerlike member, but upon the lids being reopened the force needed to foldor bend the finger like member becomes less than that imposed by thestructure of the finger like member and thus the finger like membersprings back into position thus now overcoming and elevating or liftingthe upper lid and/or depressing or lowering the lower lid. In someembodiments, but not all, of the hybrid scleral ring the finger likemember is bent or folded into a receiving trench which was pre-formed(designed) in an outer surface of the scleral ring. The location of thetrench or trenches is provided in the proper location relative to eachfinger like member. This allows for the finger like member (members) tobe folded almost flat as it blinks so that the lid can easily close oropen over the finger like member (members). It should be also pointedout that while the disclosure shows and teaches the finger like membersbeing associated with the scleral ring prosthesis they can also beassociated with a contact lens prosthesis.

The incremental zone can be comprised of a homogenous material when thescleral ring and contact lens is made of one material or a hybrid zonewhen the scleral ring or contact lens is made of two materials. In someembodiments of the prosthesis there may or may not be an incrementalthickness zone or region or a regressive thickness zone or region, butrather the surface of the zone or region is altered to provide toprovide additional lid friction. This region or zone of increasedsurface friction can be easily over come during an eye lid blink orforced closure, but upon opening the eye lid this region of increasedfriction elevates the upper lid and/or depresses the lower lid thusopening the aperture of the eye. An increased surface friction zone,region, area can be flat or raised on the convex surface of theprosthesis. An increased surface friction zone, region, area can be anaperture widening zone, region, area.

The zone of incremental thickness or increased surface friction found insome embodiments of the prosthesis taught herein can be shaped, by wayof example only, as that of a: ring (rings), ringlets, partial rings,band, bands, partial bands, dome, a series of domes, isolated regions orislands of any geometrical shape, segmented area, or segmented areas.The zone of incremental thickness is located on the convex outer surfaceof the contact lens. The zone of incremental thickness can be expressedas the area of thickness that elevates from that of the normalized outerconvex surface curvature of the contact lens or scleral ring. In most,but not all, preferred embodiments of the contact lens or scleral ringthe zone of incremental thickness (of aperture widening zone) isconnected to that of the outer convex surface curvature at the pointwhere its outer slope meets the convex surface or its inner slope meetsthe convex surface in a continuous manner (meaning the convex curvatureof the contact lens or scleral ring is that of a continuous surface). Insome other embodiments the convex surface has a discontinuity ordiscontinuities imparted there-upon which are located adjacent to ornear the region or regions of incremental thickness and thus is not acontinuous surface. When speaking of a hybrid scleral ring in someembodiments the incremental thickness zone is formed by way of adiscontinuous surface where one material is affixed to another material.When speaking of a homogenous scleral ring, the ring is made out of onematerial and in most cases utilizes an incremental thickness region(aperture widening zone) to provide the lifting of the upper lid and/orlowering of the lower lid.

The term prosthesis as used herein is meant to be one of: acorneo-scleral contact lens, or a scleral ring. The term “contact lens”as used herein is meant to be that of a corneo-scleral contact lenswhich can be one of: rigid, soft, gas perm, or hybrid.

The zone/region/area of incremental thickness (aperture widening zone)which comprises the zone of incremental thickness in most, but not all,embodiments is located on the convex surface adjacent to the outer edgeof the pupillary zone and outside the pupillary zone of the contact lensor scleral ring. The pupillary zone is the same size or smaller than thecontact lens optical zone and is located within the central openaperture of the scleral ring. The maximum thickness delta of theincremental thickness zone is located at (in alignment with) or external(outside of) to the limbus of the wearer's eye when the prosthesis beingthat of a contact lens or scleral ring is worn. This means the maximumthickness delta or maximum change in thickness of the incrementalthickness zone (aperture widening zone) is equal to or of a largerdiameter than the measurement of the limbus to limbus diameter (outsidecorneal diameter) thru the geometrical center of the cornea of the eyeto which the contact lens or scleral ring is being worn or intended tobe worn. The contact lens or scleral ring as taught herein is that of acontact lens or scleral ring comprising an incremental thickness zone,whereby the incremental thickness zone has an incremental thickness, aslope and a width, and whereby the incremental thickness diameter iswithin the range of 1 mm to 10 mm larger than the natural palpebralfissure of the wearer's eye. The zone of incremental thickness islocated on the convex surface and acts as an elevator of the upper lidand/or a depressor of the lower lid. The net cosmetic effect is to widenthe aperture or palpebral fissure (aperture) of the wearer's eye.

In some further embodiments a regressive thickness region is provided onthe convex surface design such to provide a topography that will alsocause the eye aperture widening effect. In this case the regressivethickness region forms a valley in the convex surface such to cause theupper lid to be elevated/lifted and the lower lid to belowered/depressed. The surrounding topography of the valley becomes anincremental thickness region, zone, area, etc.

In most preferred embodiments the prosthesis can remain thinner inoverall area when an incremental thickness region is added/designed, asopposed to a regressive thickness region being designed into theprosthesis. This is due to the fact that the regressive thickness regionis really the effect of a subtraction of thickness in the regressivethickness region. Thus in order to obtain (by way of a regressiveregion) the needed valley depth in the convex surface of the prosthesissuch to provide for the aperture widening effect the area locatedinternal (closer to the center of the lens) must be thicker than theregressive region. Thus the prosthesis having a regressive thicknessregion will be thicker in total surface area than that of a prosthesiscomprising an incremental thickness region. In most cases a prosthesishaving a thinner overall surface area is preferable to a thicker overallsurface area. Now having said the above, in some embodiments of theprosthesis a regressive thickness region is utilized to provide the eyeaperture widening effect.

The incremental thickness region and/or the regressive thickness regioncan be one of: rotationally symmetric, rotationally asymmetric,elliptical arch like feature (features), island or island like areas.The elliptical arch (arches) like feature (features) can resemble thecurve of lid margin of the upper lid and/or the curve of the lid marginof the lower lid. In some embodiments the incremental thickness zone canform somewhat vertical islands located on either side (right or left) ofthe optic zone (in the case of a contact lens) or open aperture (in thecase of a scleral ring).

The incremental thickness region of the prosthesis can have a maximumdelta thickness differential (added thickness) within the range of 25microns to 1,000 microns with a preferred range of 100 microns to 500microns, with a more preferred range of 100 microns to 400 microns, witha more preferred range of 75 to 400 microns. The maximum delta thicknesscan be 25 microns, 50 microns, 100 microns, 150 microns, 200 microns,250 microns, 300 microns, 350 microns, 400 microns, 450 microns, 500microns, 550 microns, 600 microns, 650 microns, 700 microns, 750microns, 800 microns, or 1000 microns. The maximum delta thicknessdifferential can be located 0.5 mm to 3 mm from the outer peripheraledge of the prosthesis. The incremental thickness region can be locatedbeginning/starting at or near the outer edge of the prosthesis to 6 mmfrom the outer edge. In some embodiments the incremental thicknessregion can be either at the outer edge or 0.1 mm to 3 mm from the outeredge of the prosthesis. The delta of maximum incremental thickness inmost cases is within a range of 0.5 mm to 3.0 mm internal to the edge ofthe prosthesis, with a preferred range of 1.0 mm to 2.5 mm internal tothe edge of the prosthesis. The incremental thickness diameter (measuredfrom the point of maximum added thickness thru the geometrical center ofthe prosthesis to the opposing point of maximum added thickness) can be:8.5 mm or greater, 9.0 mm or greater, 9.5 mm or greater, 10.0 mm orgreater, 10.5 mm or greater, 11.0 mm or greater, 11.5 mm or greater,12.0 mm or greater, or 12.5 mm or greater, or 13 mm or greater, or 13.5mm or greater, or 14.0 mm or greater.

The regressive thickness region of the prosthesis can have a maximumdelta thickness differential (reduced thickness) within the range of 25microns to 1,000 microns with a preferred range of 100 microns to 500,with a more preferred range of 100 microns to 400 microns, with a morepreferred range of 75 microns to 400 microns. The maximum deltathickness can be 25 microns, 50 microns, 100 microns, 150 microns, 200microns, 250 microns, 300 microns, 350 microns, 400 microns, 450microns, 500 microns, 550 microns, 600 microns, 650 microns, 700microns, 750 microns, 800 microns, or 1000 microns. The regressivethickness region can be located from the outer edge to 6 mm from theouter edge. In most embodiments the regressive thickness region can be0.1 mm to 3 mm from the outer edge of the prosthesis. The delta ofmaximum incremental thickness or delta of maximum regressive thickens inmost cases is within a range of 0.5 mm to 3.0 mm internal to the edge ofthe prosthesis, with a preferred range of 1.0 mm to 2.5 mm internal tothe edge of the prosthesis.

The aperture widening zone when caused by incremental thicknesscomprises two slopes divided by a point of maximum change thickness(maximum thickness delta). These two slopes are called the outer slopeand the inner slope. The “outer” slope on the side closest to the outeredge of the prosthesis of the aperture widening zone (incrementalthickness region or regressive thickness region) helps to achieve theaperture widening effect. The “outer” slope can be, by way of exampleonly, 50 microns per mm or greater, 100 microns per mm or greater, 150microns per mm or greater, 200 microns per mm or greater, 250 micronsper mm or greater, 300 microns per mm or greater, 350 microns per mm orgreater. The “inner” slope can be, by way of example only, 50 micronsper mm or less, 100 microns per mm or less, 150 microns per mm or less,200 microns per mm or less, 250 microns per mm or less, 300 microns permm or less, 350 microns per mm or less. If the “outer” slope has achange in thickness of less than 50 microns per mm the widening effectis minimized. If the outer slope has a change in thickness of greaterthan 300 microns per mm the prosthesis becomes uncomfortable and maydecenter. A range of an outer slope of the aperture widening zone on theside closest to the outer edge of the prosthesis is within a minimum of3 degrees to a maximum of 45 degrees, and preferably within a range of 5degrees to 25 degrees. A range of an “inner” slope of the aperturewidening zone on the side closest to the geometrical center of theprosthesis can be within the range of a minimum of 1 degree to a maximumof 15 degrees. In most, but not all embodiments the outer slope isgreater than the inner slope. In some embodiments the outer slope isapproximately equal to that of the inner slope. And in some embodimentsthe inner slope is greater than the outer slope.

In some embodiments, the prosthesis can comprise an aperture wideningzone (incremental thickness region or incremental regressive thicknessregion) on its convex surface, whereby the aperture widening zone causesa bump on the convex surface that provides for the aperture wideningeffect. This bump (which is caused by incremental thickness orregressive thickness) has a curvature shape, slope angle, change inthickness per millimeter and maximum change in thickness (maximum deltathickness). In some embodiments the aperture widening zone's outer slopecan begin at or adjacent to the outer peripheral edge of the prosthesisand continues to the maximum thickness delta of the aperture wideningzone. In some embodiments, when the outer slope begins at or adjacent tothe outer peripheral edge the outer slope will be within 2 degrees ofthe slope of the outer edge. In most, but not all embodiments, thelocation of the maximum thickness delta is achieved within the range of1 mm to 3 mm from the outer edge, with a preferred range of 1.0 mm to2.5 mm from the outer edge. The aperture widening zone can comprise awidth of 1 mm to 6 mm when measured from the outer edge proceedingacross the aperture widening zone towards the geometrical center of theprosthesis.

The size, shape, and configuration of the aperture widening zonedescribed herein may be tailored for individuals, or groups ofindividuals, having specific natural palpebral fissure verticaldimensions, eye aperture characteristics, and/or eyelidcharacteristics/anatomies. For example, in most but not all cases,Caucasian eyes have larger natural palpebral fissures (i.e., naturalpalpebral fissures with larger vertical dimensions) when compared toAsian eyes. As such, the size, shape, and configuration for an aperturewidening zone shown to effectively widen the natural palpebral fissureof a Caucasian eye may not work as effectively on an Asian eye.

For exemplary purposes only, for Asian eyes, a smaller overall diameterprosthesis and/or a prosthesis having a smaller incremental thicknessdiameter (or minimum vertical dimension) may be needed to providedesirable widening effects. The reason for this may be that if themaximum thickness delta, increased surface friction, etc. is located toofar up under the upper lid relative to the tarsal plate of the upper lid(or too far up under the lower lid relative to the tarsal plate of thelower lid), the lid lifting (or lowering) effect of the prosthesis mayto be minimized.

In some embodiments, the aperture widening zone must have a diameter (orminimum vertical dimension) that is at least 1 mm or larger than that ofthe vertical dimension of the vertical measurement of the naturalpalpebral fissure of the wearer's eye to provide a palpebral wideningeffect that is noticeable to an observer looking at the eye of thewearer.

Moreover, contact lenses having a large overall diameter (e.g., largerthan 14.8 mm in overall diameter) may be difficult for a wearer toinsert. While larger aperture widening zones may be placed on largecontact lenses, it may be preferable that the size, shape, andconfiguration for an aperture widening zone is tailored to fit onto arelatively small contact lens (e.g., at most 14.8 mm in overalldiameter).

The size, shape, and configuration of the aperture widening zone may betailored for lens having different overall diameters. This may beaccomplished by adjusting one or more of, but not limited to, thefollowing: the location of the aperture widening zone (i.e., thebeginning of the zone closest to the peripheral edge of a prosthesis andthe end of the zone closest to the geometrical center of theprosthesis), the outer slope width, the inner slope width, the maximumincremental/regressive thickness, and the coefficient of friction for anarea of increased surface friction.

For example, the width of the aperture widening zone outer slope for a14.5 mm lens may be 1 mm or less compared to the aperture widening outerslope zone width being approximately 1.5 mm for that of a 15.5 mm softlens. This will increase the outer slope angle for the 14.5 mm lenscompared to the outer slope angle of the 15.5 mm lens. As anotherexample, the beginning of the aperture widening zone outer slope for a14.5 mm lens, when compared to the aperture widening zone outer slopefor a 15.5 mm lens may begin closer to the peripheral edge of the lens.Thus, by adjusting one or more of the outer slope width and location ofthe aperture widening zone, both a 14.5 mm overall diameter lens andalso a 15.5 mm overall diameter lens can have, for example, a 12.5 mmaperture widening zone diameter that will have the same widening effect.

In some embodiments, the aperture widening zone diameter may be, forexample, 11.5 mm, 12.0 mm, 12.5 mm, or greater. Depending on thevertical dimension of the natural palpebral fissure of the eye of thewearer, a prosthesis having an overall diameter of 13.0 mm or larger;such as by way of example only; 13.5 mm, 13.8 mm, 14.0 mm, 14.5 mm, 14.8mm, 15.0 mm, 15.5 mm, or 16.0 mm may be preferable for a wearer.

In some embodiments, the aperture widening zone diameter, minimumvertical dimension, thickness, and slopes for an aperture widening zonemay be tailored to prevent undesirable light reflections within awearer's eyes. For example, an aperture widening zone having a largemaximum thickness delta and a small aperture widening zone diameter orminimum vertical dimension (e.g., 10 mm or smaller) may createundesirable light reflections near the pupil of a wearer. Without bebound by a specific theory, this may be due to the amount of materialused to create such an aperture widening (e.g., the lens material usedto create the outer slope, inner slope, and thickness delta). The largeamount of material may act similar to a prism, thus resulting inundesirable light reflections or refracted light that may be redirectedwithin the pupil of the eye of the wearer, which may irritate thewearer. As such, increasing the incremental thickness of an aperturewidening close to the optical/pupillary zone of a prosthesis mayexaggerate and/or increase the undesirable light reflections. An area ofincreased surface friction alone may not produce undesirable lightreflection due to a lack of incremental thickness. In some embodiments,the maximum incremental thickness (i.e., maximum added thickness delta)of an aperture widening zone may be located at least 5.5 mm or more fromthe geometrical center of a prosthesis (thus outside the night timedilated pupil diameter of the eye). Also, in certain embodiments, adistance at least 5.5 mm from the geometrical center of the prosthesismakes it possible to add an area of increased surface friction thatreduces the transmission of light to the maximum added thickness deltaof the aperture widening zone. In this case, combining (i.e.,overlapping in whole or in part) an area of increased surface frictionwith an area of incremental thickness may prevent undesired lightreflections by altering the surface characteristics of the incrementalthickness zone, thereby altering the transmission and/or reflection oflight at the surface of the prosthesis.

In some embodiments, a colored accented ring or band which is locatedaround the zone of incremental added thickness of the aperture wideningzone can also reduce irritating or annoying light reflections which canoccur in certain cases when the maximum delta thickness of an aperturewidening zone is too close to the geometrical center of a prosthesis(e.g., less than 5.5 mm from the geometrical center of the prosthesis).This occurs due to a prismatic reflection of light into the pupil of theeye at an angle which strikes a peripheral portion of the retina. And,in certain other embodiments, a combination of a colored accented ring,along with an increased surface friction zone, which also contributes tolight transmission reduction in the region of the aperture wideningzone, can also further assist in reducing and/or eliminating irritatingor annoying reflections. In still other embodiments, the colored ring orband may be located on the convex surface of the prosthesis and may bedesigned to provide increased surface friction.

Accordingly, the thickness, slopes, diameter, surface friction, and/orminimum vertical dimension of an aperture widening zone may be tailoredfor a specific individual, or set of individuals having similar eyeanatomies, to avoid undesirable light reflections.

In some embodiments, effective aperture widening may be achieved whenthe aperture widening zone's outer slope diameter, including the peak ofincremental thickness, when worn on the eye of a wearer aligns outsideof the limbus and cornea of eye of the wearer. By this it is meant thatthe outer slope of the aperture widening zone (including that of thepeak incremental thickness region) is located when worn and aligned onthe eye of a wearer external to that of the cornea and limbus of the eyeof the wearer.

Table 1 provides some exemplary aperture widening zone diameters forindividuals having palpebral fissures with various vertical dimensions.

TABLE 1 Exemplary Aperture Widening Zone Diameters for Various PalpebralFissure Vertical Dimensions Vertical Dimension of the Palpebral ApertureWidening Fissure of an Individual's Eye Zone Diameter* 10.5 mm 11.5 mm11.0 mm 12.0 mm 11.5 mm 12.5 mm 12.0 mm 13.0 mm 12.5 mm 13.5 mm 13.0 mm14.0 mm *The aperture widening zone diameter is larger than the diameterof the average human cornea + limbus in each example.

While exemplary dimensions have been discussed, it should be understoodthat the dimensions provided herein are by way of example only. However,preferably the length of the aperture widening zone diameter is 1 mm orlonger than the vertical dimension length of the palpebral fissure of awearer's eye. In some, but not all embodiments, the aperture wideningzone diameter is also larger than the diameter of the cornea plus thelimbus of the wearer's eye of the soft contact lens.

In most, but not all embodiments a least one bump is located above andbelow the geometrical center along an imaginary vertical axis thatcrosses the geometrical center of the prosthesis. In some otherembodiments a least one bump is located on either side of thegeometrical center so as to be intersected by an imaginary horizontalaxis that crosses the geometrical center of the prosthesis. Still inother embodiments multiple isolated bumps can be located so as to beintersected by an imaginary axis going through the geometrical center ofthe prosthesis, by way of example only, two or more of: 40 degrees, 45degrees, 90 degrees, 135 degrees, 150 degrees, 180 degrees, 210 degrees,and 330 degrees, relative to the geometrical center of the prosthesis.

The location of the peak delta incremental thickness (maximum change inthickness) region (zone, area) or the peak delta regressive thickness(maximum change in thickness) region (zone, area) of the prosthesis canbe located 0.1 mm or more superior (above) with respect to the upper lidmargin and/or 0.1 mm or greater inferior (below) with respect to thelower lid margin of the wearer, but more preferably located 0.5 mm ormore superior (above) to the upper lid margin and/or 0.5 mm or greaterinferior (below) to the lower lid margin of the wearer. It is importantto note that the above measurements contained in this paragraph are ofthe lids “without the prosthesis being worn” and as of the time thewearer's eye is looking straight ahead and relaxed without straining tosee clearly or in bright light (this being the natural aperture of thewearer's eye). Thus when wearing the prosthesis the upper lid iselevated by a minimum of 0.1 mm or more and/or the lower lid isdepressed (lowered) by a minimum of 0.1 mm or more. But in a morepreferred example, when wearing the prosthesis the upper lid is elevatedby a minimum of 0.5 mm or more and/or the lower lid is depressed(lowered) by a minimum of 0.5 mm or more. The aperture widening of theprosthesis can be further accentuated by way of a colored accent color.The colored accent color can be a colored limbal ring or a coloredcircle ring (which can be referred to as a colored circle lens) locatedon the prosthesis. Thus the more the wearer's eye aperture is widened bythe prosthesis which has this colored accent color, such as a coloredlimbal ring, the more colored limbal ring can be observed by someonelooking at the eye of the wearer. This provides a very complementaryeffect which makes the colored limbal ring, color ring or color accentmore dramatic in its cosmetic enhancement of the wearer's eye. A portionof the colored accent color will be located at (above and adjacent to)or external to the limbus of the wearer's eye when the color accentedprosthesis is being worn. This means that a portion of the coloraccented prosthesis is located, when worn, on top of or external to thelimbal area of the eye of the wearer. Thus the diameter of a portion ofthe colored accent portion is equal to or larger in diameter to that ofthe outside diameter of the cornea of the wearer.

In some embodiments, such as by way of example only, a prosthesis thatis of a contact lens multifocal design and/or one that corrects forastigmatism and thus requires optical power having a toric component anda stabilization zone (feature or member) is employed. In someembodiments, such as by way of example only, when a prosthesis that is ascleral ring or one that is a single vision contact lens having onlyspherical optical power the prosthesis is free to rotate upon normalblinking and thus devoid of a stabilization zone (feature, member). Insome other embodiments a stabilization zone (feature or member) isemployed for a single vision spherical power contact lens. When astabilization zone (feature or member) is employed it can be built ontoor into the design of the aperture widening zone (thus they arespecially designed to be one in the same) or it can be separate from theaperture widening zone.

An increased surface friction region/zone/area can be located on theconvex surface of the prosthesis and can increase the aperture of awearer's eye. The prosthesis can be that of a soft contact lens, hybridcontact lens, corneo-scleral contact lens, or a scleral ring. Theincreased surface friction zone/region/area can be called an aperturewidening zone/region/area. The increased surface frictionregion/zone/area can be flat, irregular, raised, or integrated on theconvex surface of the prosthesis. The increased surface frictionregion's width can have a width that includes the outer edge of theprosthesis to a point 6 mm from the outer edge. The increased surfacefriction can be expressed as a region on the convex surface of theprosthesis having a 1% increase in one of surface friction or dragfriction compared to that of other regions of the convex surface of theprosthesis. In some other embodiments the increased surface frictionregion is located within 0.1 mm and 6 mm from the outer edge of theprosthesis. Given that in certain embodiments the increased surfacefriction region can be flat and thus approximate a zone/region/area onthe convex surface of the aperture widening zone or a portion thereof ofthe prosthesis comprising an increased surface friction region theregion has no thickness slope. In other embodiments there is a thicknessslope. An increased surface friction region can be fabricated on theconvex surface of aperture widening zone of the prosthesis or a portionthereof, by way of any known means including, by way of example only:molding, thermoforming, surface treatment, coating, etching, deposition,gas etching, gas treatment, laser etching, laser treatment, chemicaletching, and chemical treatment. Any convex surface region/zone/area ofthe prosthesis located within the range of 0 mm to 6 mm from the outeredge of the prosthesis which comprises 1% or greater in one of dragfriction or surface friction compared to an area of the convex surfacelocated beyond 6 mm from the outer edge would be considered an increasedsurface friction region/zone/area. By way of example only, such anincreased surface friction convex surface region/zone/area could be: acoated surface, a dimpled surface, a crazed surface, surface bumps,surface rings, surface lines, non-slick surface, irregular surface, or acombination thereof.

The dimples, bumps, rings, and lines of the increased surfaceregion/zone/area have a vertical depth. The vertical depth is defined bythe distance between a peak and trough of the dimple, bump, ring, line,etc. The vertical depth of these features may be within the range of 500angstroms to 50 microns, and preferably within the range of 1 micron to10 microns.

While these features do have a depth resulting in a roughened and/orpatterned area, they do not alone result in an area of incrementalthickness. In some embodiments, the features may result in a roughedand/or pattered area that is flat relative to the normalized convexsurface of a prosthesis. In other words, while these features do have avertical depth, they may not extend beyond the normalized convex surfaceof a prosthesis. In such embodiments, troughs located between eachfeature are recessed below the normalized convex surface of theprosthesis. In some embodiments, the features may result in a roughedand/or pattered area that is raised relative to the normalized convexsurface of a prosthesis. In such embodiments, each feature may extendabove the normalized convex surface and troughs located between thefeatures may be located at depths that are the same as the normalizedconvex surface of the prosthesis. In some embodiments, the features mayextend above the normalized convex surface and troughs located betweenthe features may be located at depths that are recessed below thenormalized convex surface.

An area of increased surface friction may include a combination ofraised and flat areas of increased surface friction. An area ofincreased surface friction created by the coating or deposition of amaterial may be considered a raised area because the coated or depositedmaterial may extend above the normalized convex surface of theprosthesis (due to the thickness of the coated/deposited material).

The increased surface friction region/zone/area can be a stand-alonefeature located on the convex surface of the prosthesis. Or an increasedsurface friction area may be combined with (i.e., overlap with), in fullor in part, an area of incremental thickness. For example, the increasedsurface friction region/zone/area can be located on the outer slope ofan aperture widening zone or a portion thereof. But an area of increasedsurface friction itself does not have an incremental thickness.

The increased surface friction region/zone/area can also be created bynot polishing all or part of the aperture widening zone on the convexsurface of the prosthesis. This will result in a region/zone/areadefined by the aperture widening zone that has an increased surfacefriction relative to the rest convex surface, which is polished. Thesurface friction of regions on the convex surface of a prosthesis may beexpressed by the following formula:

$c_{d} = {\frac{1}{\rho\; v^{2}A}{\int_{S}{{T_{w} \cdot \hat{t} \cdot \hat{i}}\; d\; A}}}$

-   where C_(d) is friction drag coefficient,-   ρ is the mass density of a fluid (e.g., tears),-   A is the reference area,-   ν is the speed of an object relative to the fluid,-   n is the normal direction to the surface with area dA-   t is the tangential direction to the surface with area dA,-   T_(w) is the shear stress acting on the surface dA,-   i is the unit vector in direction normal to the surface dA.

In some embodiments, a region/zone/area of increased surface frictionhas a surface friction (e.g., friction drag coefficient) that is atleast 1% greater than the surface friction of a portion of the convexsurface of the prosthesis adjacent to the area of increased surfacefriction. In some embodiments, a region/zone/area of increased surfacefriction may have a surface friction that is at least 25% greater thanthe surface friction of a portion of the convex surface of theprosthesis adjacent to the area of increased surface friction. In someembodiments, a region/zone/area of increased surface friction may have asurface friction that is at least 33% greater than the surface frictionof a portion of the convex surface of the prosthesis adjacent to thearea of increased surface friction. In some embodiments, aregion/zone/area of increased surface friction may have a surfacefriction that is at least 50% greater than the surface friction of aportion of the convex surface of the prosthesis adjacent to the area ofincreased surface friction.

The percentage difference between the surface friction for theregion/zone/area of increased surface friction and the portion of theconvex surface adjacent to the region/zone/area of increased surfacefriction (e.g., percentage difference between friction dragcoefficients) may depend on the coefficient of friction (e.g., frictiondrag coefficient) of the material used to make the prosthesis. Forexample, the percentage difference for a prosthesis made with a materialhaving a coefficient of friction equal to 1.0 may be greater than thepercentage difference for a prosthesis made with a material having acoefficient of friction equal to 1.5. Additionally, the percentagedifference may depend on the size and configuration of theregion/zone/area of increased surface friction. As a non-limitingexample, a region/zone/area of increased surface friction that has arelatively thin increased surface friction zone width (e.g., a ringhaving a width of x) may have a larger percentage difference incoefficient of friction compared to a region/zone/area of increasedsurface friction having a relatively thick increased surface frictionzone width (e.g., a ring having a width of 3×).

Moreover, the percentage difference may depend on whether or not theregion/zone/area of increased surface friction overlaps, in whole or inpart, an area of incremental thickness. As a non-limiting example, aregion/zone/area of increased surface friction that overlaps, in wholeor in part, an area of incremental thickness may achieve the samewidening effects with a percentage difference that is smaller than aregion/zone/area of increased surface friction (flat or raised) alone.This may be due to widening effects imparted by the incrementalthickness, which is separate from the widening effect imparted by theincreased surface friction. Accordingly, the percentage difference mayalso depend on the maximum thickness delta of the area of incrementalthickness.

FIGS. 12A-B and 13A-B illustrate two ways in which an aperture wideningzone is capable of widening the palpebral fissure of an individual'seyes. FIGS. 12A and 13A show an individual not wearing a prosthesis asdescribed herein and FIGS. 13A and 13B show the same individual with aprosthesis having an aperture widening zone superimposed onto her eyes.

FIG. 12B shows an embodiment of a prosthesis 1200 whereby a maximumdelta thickness 1202 falls outside of the natural aperture of the eye.Said another way, when worn the maximum delta thickness 1202 of anaperture widening zone (zones) of the prosthesis 1200 is located abovethe upper lid margin and below the lower lid margin when the eye isrelaxed and looking straight ahead. The incremental thickness diameter(which is the diameter measured from a point of maximum added thicknessthru the geometrical center of the prosthesis to the opposing point ofmaximum added thickness) is larger than the distance between the upperlid margin and the lower lid margin.

The incremental thickness diameter and also the regressive thicknessdiameter is the distance along an axis from a point of maximum deltathickness proceeding through the geometrical center of the prosthesis ina straight line to that of a point of maximum delta thickness located onthe opposite side from the previous point of maximum delta thickness.The embodiments disclosed herein teach when fitting the prosthesis tofit the prosthesis whereby the maximum delta thickness (also called thepeak thickness delta) is located at a minimum 0.1 mm above with respectto the upper lid margin and/or 0.1 mm below with respect to the lowerlid margin.

The incremental thickness diameter and the regressive thickness diameterof the prosthesis can be of any diameter depending upon the overalldiameter (outer most diameter) of the prosthesis, however, in most casesthe incremental and regressive thickness diameter is within the range of8.5 mm or greater.

The location of the maximum delta thickness 1202 on prosthesis 1200 islocated under and above with respect to the upper lid margin and locatedunder and below with respect to the lower lid margin, thus widening thepalpebral fissure (aperture) of the eye. To be clear in this embodimentthe location of the maximum delta thickness does not fall within thenatural aperture of the eye as it falls outside or a larger distancemeasurement than the vertical measurement of the natural aperture of theeye (meaning the incremental thickness diameter is greater than thevertical measurement of the natural eye aperture). In the case of thisembodiment the upper eye lid is lifted due to the aperture widening zonebeing one or more of an incremental thickness zone, regressive thicknesszone, or increased surface friction region. And the lower lid is pusheddown also due to the aperture widening zone being one or more of anincremental thickness zone, regressive thickness zone, or increasedsurface friction region. The method of action in the case of anembodiment having an incremental thickness zone (region, area) resultsby way of either the added thickness pushing out and up the upper lidand pressing down and out the lower lid. The method of action in thecase of an embodiment having a regressive thickness zone (region, area)results by way of either the upper lid margin and lower lid margin beingcontacted by the slope where the regressive thickness zone border beginsto add significant thickness on the side closest to the pupil of the eyeor being contacted and held within the valley of the regressivethickness zone. The method of action in the case of an embodiment havingan increased surface friction (region, area) results by way of eitherthe added thickness pushing out and up the upper lid and pressing downand out the lower lid.

FIG. 13B shows the location of a maximum delta thickness 1302 on aprosthesis 1300 being located at the upper lid margin and the lower lidmargin. Note how the dotted lines in FIG. 13B are smaller in diameter(the incremental thickness diameter or the regressive thicknessdiameter) compared to the same dotted lines of the embodiment describedin FIG. 12B. FIG. 12B has a larger incremental thickness diameter orregressive thickness diameter compared to FIG. 13B. The method of actionof this embodiment utilizes the outer slope across the width of theincremental thickness zone to accomplish the widening effect. By havinga steep slope (crossing the incremental thickness zone width or theregressive thickness zone width) which ascends (grows) in thickness fromits beginning on the side facing the outer edge of the of the prosthesis1300 to the maximum delta thickness 1302 located just inside of thenatural aperture of the eye, the slope acts as a sliding board or prismshaped wedge that causes the upper lid to move up and the lower lid tomove down thus opening the eye's aperture. With this embodiment it ispossible for the incremental thickness diameter or regressive thicknessdiameter to have a maximum delta thickness that falls within thenormal/natural aperture of the eye.

FIGS. 14A-17B illustrate various embodiments of aperture wideningzones/incremental thickness regions present on the convex surface of aprosthesis.

FIG. 14A illustrates a scleral ring 1400 according to one embodiment.Scleral ring 1400 has a central open aperture 1404 with a geometriccenter 1402 located in the center. Scleral ring 1400 includes twoincremental thickness regions 1408 located on opposite sides of openaperture 1404. Each incremental thickness region 1408 has a maximumincremental thickness (peak delta thickness) 1406. Incremental thicknessregions 1408 are capable of increasing the palpebral fissure of awearer's eye when worn,

FIG. 14B illustrates a contact lens 1450 according to anotherembodiment. Contact lens 1450 has an optical region 1454 with ageometric center 1452 located in the center. Contact lens 1450 includestwo incremental thickness regions 1458 located on opposite sides ofoptical region 1454 both in the shape of raised islands. Eachincremental thickness region 1458 has a maximum incremental thickness(peak delta thickness) 1456. Incremental thickness regions 1458 arecapable of increasing the palpebral fissure of a user's eye when worn.

FIG. 15A illustrates a contact lens 1500 according to anotherembodiment. Contact lens 1500 includes an optic zone 1502 surrounded bya ring-shaped incremental thickness or regressive thickness region 1504.Contact lens 1500 also includes a regressive thickness region 1506surrounding incremental thickness or regressive thickness region 1504and extending towards the edge of contact lens 1500.

FIG. 15B illustrates a contact lens 1520 according to anotherembodiment. Contact lens 1520 includes an optic zone 1522 surrounded byan oval-shaped incremental thickness or regressive thickness region 1524Contact lens 1520 also includes a regressive thickness region 1526surrounding incremental thickness or regressive thickness region 1524and extending towards the edge of contact lens 1520.

FIG. 15C illustrates a contact lens 1540 according to anotherembodiment. Contact lens 1540 includes an optic zone 1542 with twoincremental thickness or regressive thickness regions 1544 locatedaround it, one above and one below. Each incremental thickness orregressive thickness region 1544 has a partial-ring shape. Contact lens1540 also includes a regressive thickness region 1546 located outside ofincremental thickness or regressive thickness regions 1524 and extendingtowards the edge of contact lens 1540.

FIG. 15D illustrates a contact lens 1560 according to anotherembodiment. Contact lens 1560 includes an optic zone 1562 with aplurality of band-shaped incremental thickness or regressive thicknessregions 1564. Incremental thickness or regressive thickness regions 1564are located around optic zone 1562 in a spoke-like fashion. Incrementalthickness or regressive thickness regions 1564 can extend to the edge ofcontact lens 1560 (as shown) or can extend to a point inside of the edge(not shown).

FIG. 16A illustrates a scleral ring 1600 according to anotherembodiment. Scleral ring 1600 includes an open central aperture 1602surrounded by a ring-shaped incremental thickness or regressivethickness region 1604. Scleral ring 1600 also includes a regressivethickness region 1606 surrounding incremental thickness or regressivethickness region 1604 and extending towards the edge of scleral ring1600.

FIG. 16B illustrates a scleral ring 1620 according to anotherembodiment. Scleral ring 1620 includes an open central aperture 1622surrounded by an oval-shaped incremental thickness or regressivethickness region 1624. Scleral ring 1620 also includes a regressivethickness region 1626 surrounding incremental thickness or regressivethickness region 1624 and extending towards the edge of scleral ring1620.

FIG. 16C illustrates a scleral ring 1640 according to anotherembodiment. Scleral ring 1640 includes an open central aperture 1642with two incremental thickness or regressive thickness regions 1644located around it, one above and one below. Each incremental thicknessor regressive thickness region 1644 has a partial-ring shape. Scleralring 1640 also includes a regressive thickness region 1646 locatedoutside of incremental thickness or regressive thickness regions 1624and extending towards the edge of scleral ring 1640.

FIG. 16D illustrates a scleral ring 1660 according to anotherembodiment. Scleral ring 1660 includes an open central aperture 1662with a plurality of band-shaped incremental thickness or regressivethickness regions 1664. Incremental thickness or regressive thicknessregions 1664 are located around open central aperture 1662 in aspoke-like fashion. Incremental thickness or regressive thicknessregions 1664 can extend to the edge of scleral ring 1660 (as shown) orcan extend to a point inside of the edge (not shown).

FIGS. 17A-C illustrate various embodiments of a contact lens having anincreased surface friction region(s). FIG. 17A shows a contact lens 1700having an optical region 1702 and a ring-shaped increased surfacefriction region 1704 surrounding optical region 1702. FIG. 17B shows acontact lens 1710 having an optical region 1712 and an oval-shapedincreased surface friction region 1714 surrounding optical region 1712.FIG. 17C shows a contact lens 1720 having an optical region 1722 and twoincreased surface friction regions 1724 located around optical region1722, one above and one below. Each increased surface friction region1724 has a partial-ring shape.

FIGS. 17D-F illustrate various embodiments of a scleral ring having anincreased surface friction region(s). FIG. 17D shows a scleral ring 1730having a central open aperture 1732 and a ring-shaped increased surfacefriction region 1734 surrounding central open aperture 1732. FIG. 17Eshows a scleral ring 1740 having a central open aperture 1742 and anoval-shaped increased surface friction region 1744 surrounding centralopen aperture 1742. FIG. 17F shows a scleral ring 1750 having a centralopen aperture 1752 and two increased surface friction regions 1754located around central open aperture 1752, one above and one below. Eachincreased surface friction region 1754 has a partial-ring shape.

The prosthesis allows for modifying “one of more” of the following tooptimize the lid lifting effect or palpebral (aperture) widening effectof the prosthesis:

1) Overall Diameter

In most, but not all cases for fitting a small eye aperture (palpebralfissure), a medium to large diameter may be most effective. With most,but not all, Caucasian eye apertures a larger overall diameter of 15.0mm to 15.5 mm may be most effective. By way of example only for smalleye apertures an overall diameter of 13.0 mm, 13.58 mm, 14.0 mm and 14.5mm appear to work well in the case of a scleral ring the outer diametermay be any of the above diameters or it could 16.0 mm or larger. In someembodiments, smaller eyes having palpebral fissures less than, forexample, 9.5 mm in the vertical dimension, the overall diameter of theprosthesis most, but not all, can range from 13.0 mm to 14.5 mm. But, insome embodiments, the overall diameter may be larger than 14.5 mm.However, regardless of the overall diameter, the incremental thicknessdiameter may remain within the range of 8.5 mm to 12.5 mm, or larger. Assuch, the distance between the outer peripheral edge and the location ofthe incremental thickness delta of the aperture widening zone may varyfrom lens to lens depending upon the incremental thickness diameter andthe overall diameter of a given lens.

2) Overall Thickness

In most, but not all embodiments, a larger overall thickness is mosteffective.

3) Edge Thickness

In most, but not all embodiments, the extreme peripheral edge thicknessof the contact lens or scleral ring is left unchanged from that normallyprovided by a contact lens manufacturer of a specific brand lens, of aspecific type, and of a specific optical power. Thus the outer edge inmost cases, but not all cases, approximates that of a conventionalcorneo-scleral contact lens.

In some embodiments the extreme peripheral edge thickness is increasedin thickness.

In most, but not all embodiments, the extreme peripheral edge thicknessof the contact lens or scleral ring is left unchanged from that normallyprovided by a contact lens manufacturer of a specific brand lens, of aspecific type, and of a specific optical power. Thus the outer edge inmost cases, but not all cases, approximates that of a conventionalcorneo-scleral contact lens.

4) Location of Maximum Added Thickness or Maximum Thickness Delta

In certain embodiments an area inside (towards the center of theprosthesis from the outer edge) of 0.5 mm from the outer edge to 3 mmfrom the outer edge of the contact lens is increased in thickness. Inother embodiments an area inside (towards the center of the prosthesisfrom the outer edge) of 0.5 mm from the outer edge to 7 mm from theouter edge of the contact lens is increased in thickness. In theseembodiments the “width” of the aperture widening zone can be within arange of 2.5 mm to 6.5 mm depending upon the overall diameter of thecontact lens. In certain other embodiments the width of the aperturewidening zone can be within the range of 1 mm to 7 mm, once againdepending upon the overall diameter of the contact lens. In someembodiments the aperture widening zone extends from the outer edge ofthe prosthesis to within the range of 2.5 mm to 5 mm inside of the outeredge of the prosthesis. The precise distance from the outer edge dependsupon the type of prosthesis, the incremental thickness diameter and alsothe overall diameter of the prosthesis.

In most, but not all embodiments, an area within a range of 0.5 mm to2.5 mm from the extreme peripheral edge of the prosthesis provides themaximum delta thickness (but preferably within the range of 0.5 mm to2.0 mm from the extreme peripheral edge of the contact lens or scleralring).

5) Regions of Incremental Thickness

In most, but not all embodiments, a region or regions of incrementalthickness or regressive thickness are located adjacent to or outside 3.0mm of the geometrical center of the contact lens. Region or regions ofincremental thickness or regressive thickness are generally locatedadjacent to or outside the pupillary zone of the contact lens or scleralring open aperture.

Such a region or regions can comprise an area or areas on the convexsurface of the contact lens, by way of example only, a ring, (rings)band, (bands) or partial rings (ringlets), dome (domes), island(islands), segmented area, segmented areas or of any geometrical shape.The region can be that of a rotationally symmetric region or arotationally asymmetric region.

In most, but not all embodiments, in the region or regions ofincremental thickness the surface geometry of the region or regions iscomprised of an increased convex curvature.

In most, but not all embodiments, in region or regions of incrementalthickness the surface geometry comprises a continuous surface with thatof the overall convex surface of the contact lens or scleral ring.

In most, but not all contact lens embodiments, in the region or regionsof incremental thickness the curvature change does not provide anyvisual correction for the wearer. In all scleral ring embodiments, inthe region or regions of incremental thickness the curvature change doesnot provide any visual correction for the wearer. In most, but not allembodiments, incremental thickness can range from 0.1 microns to 1,000microns. In most, but not all embodiments of the prosthesis theincremental thickness region can have a point of maximum addedthickness. The maximum added thickness can range from 25 microns to 1000microns. In some embodiments the maximum change in thickness/maximumthickness delta is within a range of 100 microns to 500 microns. In someembodiments the maximum change in thickness is within a range of 75microns to 400 microns.

6) Increased Surface Friction

Embodiments that utilize increased surface friction can be that ofsurface friction on the convex surface of the prosthesis forming theaperture widening zone or as part of the incremental thickness zone.

In most, but not all embodiments, the touch area of slide resistancebetween the contact lens or scleral ring and the lid or lids isincreased. This is accomplished by increasing the friction between thelid (lids) and the convex surface of the contact lens, but doing so insuch a limited way that it is accomplished without irritating the lid(lids). A difference of 1% or more of increased drag friction within theaperture widening zone can be meaningful compared to the surfacefriction of the rest of the prosthesis outside of the aperture wideningzone.

Area of increased surface friction differs from area having anincremental thickness. First, the widening effect of an area ofincreased surface friction results from an increase in surface friction(e.g., friction drag coefficient), not from an increase or decrease inthickness. Second, an area of increased surface friction may not add asignificant amount of weight to an area of the prosthesis. Incrementalthickness areas add weight because a significant amount of material maybe used to create the inner slope(s), outer slope(s), and maximumthickness delta(s). In contrast, an area of increased surface frictionis either flat or only slightly raised (e.g., raised dimples or a coatedor deposited material), which may result in less added weight.

Third, the interaction between an eyelid and an area of incrementalthickness may be different than the interaction between an eyelid anarea of increased surface friction. For example, as an upper eyelid isopening, the eyelid will pass over an area of incremental thickness(including the maximum thickness delta) thereby tending to pull the areaof incremental thickness (and the prosthesis) upward. But once the uppereyelid passes the maximum delta thickness (e.g., when it is fully open)it will begin to push the area of increased thickness (and theprosthesis) downward. In the case of stabilization zones located on aprosthesis, interaction between an eyelid and an area of incrementalthickness may be used to stabilize a prosthesis within an eye by causingrotation into a specific rotational position. The position is held bythe upper eyelid pushing down on the area of incremental thickness whenthe eyelid is open. The same interaction may occur for the lower eyelid,expect for the lower eyelid will tend to push areas of incrementalthickness upward, rather than downward.

In contrast, an area of increased surface friction does not have thesame interaction with an eyelid once the eyelid is open. While theeyelid may push down/up the area of increased surface friction, it willnot tend to cause rotation. The lack of incremental thickness (i.e.,slope) results in a lack of rotation because of the lack of slopedsurfaces for the eyelid to force downward/upward and towards a desiredrotational position.

7) Convex Surface Shape

In most, but not all embodiments, the convex surface shape near and/oraround the periphery of the contact lens is altered compared to thatnormally provided by a contact lens manufacturer of a specific brandlens, of a specific type, and of a specific optical power.

8) Slope difference

In most embodiments the steepest slope is that of the outer slope of theincremental thickness region and the less steep slope is on the innerslope of the incremental thickness region which is closest to thegeometrical center of the contact lens or scleral ring.

In certain embodiments the steepest slope is that of the inner slope ofthe incremental thickness region and the less steep slope is on theouter slope of the incremental thickness region which is closest to theouter edge of the contact lens or scleral ring.

In certain other embodiments the outer slope of the incrementalthickness region is equal to the inner slope of the incrementalthickness region

9) Lens Material

In most, but not all embodiments, the lens material is that of one of asilicone hydrogel or a hydrogel material.

In some embodiments the lens material is that of one of a gas permeablematerial or a rigid material.

In some embodiments a different material is added/bonded, inserted,affixed to the contact lens or scleral ring thus altering a region(regions) or area (areas) of the contact lens convex outer surfacematerial.

In some other scleral ring embodiments the scleral ring is made ofnon-gas perm material.

In some other embodiments the scleral ring material is that of a rigidnon-gas permeable material.

10) Edge Shape of the Prosthesis

In most, but not all embodiments, the extreme peripheral edge shape isnot altered from that which is available for a specific brand, of aspecific contact lens type, of a specific contact lens optical power.

In some embodiments the edge shape is altered to have a steeper slope onthe convex surface internally from the peripheral edge of the contactlens or scleral ring when compared to that available for a specificbrand, and of a specific contact lens type, of a specific contact lensoptical power.

In some embodiments the edge shape is altered to be a less steep slopeinternally from the peripheral edge of the contact lens or scleral ringcompared to that available for a specific brand, of a specific contactlens type, and of a specific contact lens optical power.

The edge thickness is preferably between 25 and 100 microns. Fordisposable type contact lenses the edge thickness is preferably between25 and 50 microns. For non-disposable type contact lenses the edgethickness is preferably between 30 and 60 microns. The edge can be ahave a knife edge shape, a rounded shape, a semi-round shape, or a bluntshape.

11) Edge Treatment

In some, but not all, embodiments a portion of the edge of the contactlens or scleral ring is truncated. In some other embodiments twoportions (one located adjacent to the upper lid, and one locatedadjacent to the lower lid) are truncated.

In some, but not all, embodiments the edge is associated with a prismballast.

In some, but not all, embodiments the edge of the lens is weighted.

12) Base Curve

In most, but not all, embodiments the base curve of the contact lens orscleral ring is increased to be steeper than that normally fit on thecornea or eye of a wearer (with the understanding that, in most but notall cases, the scleral ring is not fit on the cornea of a wearer). Ifthe scleral ring is fit on the cornea it fits only on the peripheralcornea outside of the pupillary zone.

In some, but not all, embodiments the base curve of the contact lens orscleral ring is decreased to be less steep than normally fit on thecornea or eye of a wearer (with the understanding that, in most but notall cases, the scleral ring is not fit on the cornea of a wearer). Ifthe scleral ring is fit on the cornea it fits only on the peripheralcornea outside of the pupillary zone.

In some, but not all, embodiments the base curve of the contact lens orscleral ring is the same as that normally fit on the cornea or eye of awearer (with the understanding that the scleral ring, in most but notall cases, is not fit on the cornea of a wearer).

13) Convex Surface Texture

In some, but not all, embodiments the convex surface texture of thecontact lens or scleral ring can have a region, regions, area, areas ofby way of example only; dimples, non-smooth surface, bumps,irregularities, less slick than the area of the prosthesis outside ofthe aperture widening zone and indentations. This surface texturegenerally covers or is a portion of the aperture widening zone. Also,this surface texture may result in an increased surface frictioncompared to the portion of the convex surface lacking the surfacetexture.

14) Optical Power

It should be pointed out that the contact lens disclosed hereincontemplates all prescription lens powers including that of plano (nopower).

The embodiments of the prosthesis (being that of a contact lens and ascleral ring) disclosed herein contemplate the need for a fitting setthat the professional will use to test fit on a patient to ensure thebest lid lifting result possible for that patient. The fitting set canprovide for one or more of the above 14 variables to be tested on thepatient to customize and understand the single best variable to alter ora combination of variables to alter when prescribing the contact lens.However, it has been determined that with an optimal fitting set 2 to 6trial contact lenses should be enough for fitting the majority of allpotential wearers.

It should be pointed out that the scleral ring disclosed comprises anopen central aperture and “no” optical power. FIGS. 18-23 show variousindividuals' eyes with and without a prosthesis having an aperturewidening zone.

FIG. 18 shows a 65 year old male's natural eyes, i.e. him not wearing aprosthesis having an incremental thickness region. In contrast, FIG. 19shows him wearing a prosthesis with an incremental thickness region(aperture widening zone). It can be seen, by comparing FIGS. 18 and 19,that the palpebral fissures of his eyes are widened when wearing aprosthesis having an incremental thickness region as described herein.The prosthesis being worn in FIG. 19 has a base thickness of 100 micronsand an incremental thickness region having an overall thickness of 300microns, with the peak thickness delta or maximum thickness added being200 microns.

FIGS. 20-21 show the widening of a 45 year old female's palpebralfissure. FIG. 20 shows her natural eye and FIG. 21 shows her wearing aprosthesis having an incremental thickness region on her eye. As can beseen the upper lid has been raised in FIG. 21 when compared to FIG. 20.The prosthesis being worn in FIG. 21 has an incremental thickness region(aperture widening zone) with a maximum added thickness or maximumthickness delta of 600 microns.

FIGS. 22A-B show the eye of a 66 year old male. FIG. 22A shows hisnatural right eye having a ptosis of the upper lid and FIG. 22B showshim wearing a prosthesis having an incremental thickness region(aperture widening zone) on the same eye. It can be seen, in FIG. 22B,that the prosthesis with an incremental thickness region lifts his upperright eyelid. Thus opening/enlarging the aperture quite dramatically.

FIG. 23 shows the right and left eye of a 40 year old female. She iswearing a prosthesis having an incremental thickness region in her righteye (left side of FIG. 23). She is not wearing a prosthesis in her lefteye (right side of FIG. 23). The prosthesis in her right eye hassubstantially widened the aperture/palpebral fissure of her right eyewhen compared to her left eye. The prosthesis being worn on her righteye has an incremental thickness region (aperture widening zone) with amaximum increased thickness/maximum thickness delta of 200 micronslocated approximately 1.5 mm inside the outer peripheral edge of theprosthesis.

FIG. 24A shows a male's natural eyes, i.e. him not wearing a prosthesishaving an incremental thickness region. In contrast, FIG. 24B shows himwearing a prosthesis with an incremental thickness region (aperturewidening zone). It can be seen, by comparing FIGS. 24A and 24B, that thepalpebral fissures of his eyes are widened when wearing a prosthesishaving an incremental thickness region as described herein.

FIGS. 25A-C show various surface profiles for three differentprostheses. Lenses 2520, 2540 and 2560 all have a geometric centerlocated at 2500 and a pupil zone indicated by lines 2502. Each lens2520, 2540, and 2560 has an incremental thickness region 2522, 2542, and2546, respectively. Note the outer slope of the incremental thicknessregion 2522 in FIG. 25A is less than the inner slope of the incrementalthickness region. Note the outer slope of the incremental thicknessregion 2542 in FIG. 25B is greater than the inner slope of theincremental thickness region. Note the outer slope of the incrementalthickness region 2546 in FIG. 25C is greater than the inner slope of theincremental thickness region.

Incremental Thickness Zone Width: The width of the incremental thicknesszone or region is the distance measured from its beginning (whereincremental thickness begins) on the side towards the outer edge of theprosthesis to the end of the zone or region (where incremental thicknessends) on the side towards the center of the prosthesis. The width ofthis zone or region generally ranges between 1 mm to 7 mm, but in somecases is between 2.5 mm and 6.5 mm, and in most cases is between 2.5 mmand 5 mm.

Increased Surface Friction Zone Width: The width of the increasedsurface friction zone or region is the distance measured from itsbeginning (where increased surface friction begins) on the side towardsthe outer edge of the prosthesis to the end of the zone or region (whereincreased surface friction ends) on the side towards the center of theprosthesis. The width of this zone or region generally ranges between 1mm to 7 mm, but in some cases is between 2.5 mm and 6.5 mm, and in mostcases is between 2.5 mm and 5 mm.

Incremental Thickness Profile of the prosthesis can be of an incrementalthickness zone that ranges between 0.1 microns to 1,000 microns ofincremental thickness. The incremental thickness zone can start at oradjacent to the outer edge of the prosthesis. The maximum deltaincremental thickness/maximum added thickness ranges between 25 micronsand 1,000 microns, preferably between 100 microns to 800 microns with apreferred delta of 100 microns to 500 microns and a more preferred rangebeing 75 microns to 400 microns. In certain embodiments an area inside(towards the center of the prosthesis from the outer edge) of 0.5 mmfrom the outer edge to 3 mm from the outer edge of the contact lens isincreased in thickness. In other embodiments an area inside (towards thecenter of the prosthesis from the outer edge) of 0.5 mm from the outeredge to 7 mm from the outer edge of the contact lens is increased inthickness. In these embodiments the “width” of the aperture wideningzone can be within a range of 2.5 mm to 6.5 mm depending upon theoverall diameter of the contact lens. In other embodiments the width ofthe aperture widening zone can be within the range of 1 mm to 7 mm, onceagain depending upon the overall diameter of the contact lens. In someembodiments the aperture widening zone extends from the outer edge ofthe prosthesis to within the range of 2.5 mm to 5 mm inside of the outeredge of the prosthesis. The precise distance from the outer edge dependsupon the type of prosthesis and also the overall diameter of theprosthesis

In most, but not all embodiments, an area inside of 0.5 mm to 2.5 mmfrom the extreme peripheral edge of the prosthesis provides the maximumdelta thickness, but preferably within the range of 0.5 mm to 2.0 mmfrom the extreme peripheral edge of the contact lens or scleral ring.

FIG. 26 is an illustration of the thickness profiles of the externalconvex surface from the edge to the center for some embodiments of theprosthesis described herein. The illustration shows different possibleexamples of the convex surface profile (slope) and also the incrementalthickness region or zone.

FIGS. 27 A-E illustrate various incremental thickness regions for fivedifferent prostheses 2710, 2720, 2730, 2740, and 2750. Each prosthesis2710, 2720, 2730, 2740, and 2750 has a pupil zone 2700 surrounded byareas of incremental thickness. FIG. 27A shows prosthesis 2710 havingincremental thickness regions 2712 and 2714. FIG. 27B shows prosthesis2720 having incremental thickness regions 2722, 2724, 2726, and 2728.FIG. 27C shows prosthesis 2720 having incremental thickness regions 2732and 2734. FIG. 27D shows prosthesis 2740 having incremental thicknessregions 2742 and 2744. FIG. 27E shows prosthesis 2750 having incrementalthickness regions 2752, 2754, 2756, and 2758.

FIGS. 28-34 are perspective views of various contact lenses havingvarious types of aperture widening zones. While FIGS. 28-34 allillustrate contact lenses it will be appreciated that the same featuresdescribed in reference to FIGS. 28-34 could be incorporated onto ascleral ring. FIG. 28 shows a contact lens 2800 having a convex surface2802, a concave surface 2804, and a peripheral edge 2806. An incrementalthickness region 2810 is located on convex surface 2802. Incrementalthickness region 2810 can be a continuous ring of increased thickness ora plurality of discontinuous partial rings of increased thickness.Incremental thickness region 2810 is located interior of peripheral edge2806 and has a thickness different from the rest of the contact lens2800. The thickness profile of the lens is illustrated by a firstthickness 2812, a second thickness 2814, a third thickness 2816, and afourth thickness 2818. First thickness 2812, third thickness 2816, andfourth thickness 2818 are equal to the standard thickness of aconventional contact lens. Second thickness 2814, located in theincremental thickness region 2810, has a thickness greater than thestandard thickness.

FIG. 29 shows a contact lens 2900 having a convex surface 2902, aconcave surface 2904, and a peripheral edge 2906. An increased surfacefriction region 2910 is located on convex surface 2902. Increasedsurface friction region 2910 can be a continuous ring having increasedsurface friction or a plurality of discontinuous partial rings havingincreased surface friction. Increased surface friction region 2910 islocated interior of peripheral edge 2906 and has a surface frictiondifferent from the rest of the contact lens 2900. The surface frictionprofile of convex surface 2902 is illustrated by a first surfacefriction 2912, a second surface friction 2914, a third surface friction2916, and a fourth surface friction 2918. First surface friction 2912,third surface friction 2916, and fourth surface friction 2918 are equalto the standard surface friction of a conventional contact lens. Secondsurface friction 2914, located in the increased surface friction region2910, has a surface friction greater than the standard surface friction.

FIG. 30 shows a contact lens 3000 having a convex surface 3002, aconcave surface 3004, and a peripheral edge 3006. An incrementalthickness and increased surface friction region 3010 is located onconvex surface 3002. Incremental thickness and increased surfacefriction region 3010 can be a continuous ring having incrementalthickness and increased surface friction or a plurality of discontinuouspartial rings or areas having incremental thickness and increasedsurface friction. Incremental thickness and increased surface frictionregion 3010 is located interior of peripheral edge 3006 and has athickness and surface friction different from the rest of the contactlens 3000. The thickness and surface friction profile of convex surface3002 is illustrated by a first thickness and surface friction 3012, asecond thickness and surface friction 3014, a third thickness andsurface friction 3016, and a fourth thickness and surface friction 3018.First thickness and surface friction 3012, third thickness and surfacefriction 3016, and fourth thickness and surface friction 3018 are equalto the standard thickness and standard surface friction of aconventional contact lens. Second thickness and surface friction 3014,located in the incremental thickness and increased surface frictionregion 3010, has a thickness and surface friction that are greater thanthe standard thickness and surface friction.

FIG. 31 shows a contact lens 3100 having a convex surface 3102, aconcave surface 3104, and a peripheral edge 3106. An incrementalthickness region 3110 is located on convex surface 3102. Incrementalthickness region 3110 can be a continuous ring of increased thickness ora plurality of discontinuous partial rings or areas of increasedthickness. Incremental thickness region 3110 is located interior ofperipheral edge 3106 and has a thickness different from the rest of thecontact lens 3100. The thickness profile of the lens is illustrated by afirst thickness 3112, a second thickness 3114, a third thickness 3116,and a fourth thickness 3118. First thickness 3112, third thickness 3116,and fourth thickness 3118 are equal to the standard thickness of aconventional contact lens. Second thickness 3114, located in theincremental thickness region 3110, has a thickness greater than thestandard thickness. Contact lens 3100 also has a small truncation 3120on peripheral edge 3106.

FIG. 32 shows a contact lens 3200 having a convex surface 3202, aconcave surface 3204, and a peripheral edge 3206. An incrementalthickness region 3210 is located on convex surface 3202. Incrementalthickness region 3210 can be a continuous ring of increased thickness ora plurality of discontinuous partial rings or areas of increasedthickness. Incremental thickness region 3210 is located interior ofperipheral edge 3206 and has a thickness different from the rest of thecontact lens 3200. The thickness profile of the lens is illustrated by afirst thickness 3212, a second thickness 3214, a third thickness 3216,and a fourth thickness 3218. First thickness 3212, third thickness 3216,and fourth thickness 3218 are equal to the standard thickness of aconventional contact lens. Second thickness 3214, located in theincremental thickness region 3210, has a thickness greater than thestandard thickness. Contact lens 3200 also has a small truncation 3220and a prism ballast 3222 located on peripheral edge 3206. Smalltruncation 3220 is located opposite prism ballast 3222 on peripheraledge 3206.

FIG. 33 shows a contact lens 3300 having a convex surface 3302, aconcave surface 3304, and a peripheral edge 3306. An incrementalthickness region 3310 is located on convex surface 3302. Incrementalthickness region 3310 can be a continuous ring of increased thickness ora plurality of discontinuous partial rings or areas of increasedthickness. Incremental thickness region 3310 is located interior ofperipheral edge 3306 and has a thickness different from the rest of thecontact lens 3300. The thickness profile of the lens is illustrated by afirst thickness 3312, a second thickness 3314, a third thickness 3316,and a fourth thickness 3318. First thickness 3312, third thickness 3316,and fourth thickness 3318 are equal to the standard thickness of aconventional contact lens. Second thickness 3314, located in theincremental thickness region 3310, has a thickness greater than thestandard thickness. Contact lens 3300 also has a small truncation 3320and a small truncation/prism ballast 3322 on peripheral edge 3306. Smalltruncation 3320 is located opposite small truncation/prism ballast 3322on peripheral edge 3306.

FIG. 34 shows a contact lens 3400 having a convex surface 3402, aconcave surface 3404, and a peripheral edge 3406. An incrementalthickness region 3410 is located on convex surface 3402. Incrementalthickness region 3410 can be a continuous ring of increased thickness ora plurality of discontinuous partial rings or areas of increasedthickness. Incremental thickness region 3410 is located interior ofperipheral edge 3406 and has a thickness different from the rest of thecontact lens 3400. The thickness profile of the lens is illustrated by afirst thickness 3412, a second thickness 3414, a third thickness 3416,and a fourth thickness 3418. First thickness 3412, third thickness 3416,and fourth thickness 3418 are equal to the standard thickness of aconventional contact lens. Second thickness 3414, located in theincremental thickness region 3410, has a thickness greater than thestandard thickness. Contact lens 3400 also has a small truncation/prismballast 3422 located on peripheral edge 3406.

FIGS. 35-38 show aerial views of a plurality of contact lenses havingvarious types of aperture widening zones. While FIGS. 35-38 allillustrate contact lenses it will be appreciated that the same featuresdescribed in reference to FIGS. 35-38 could be incorporated onto ascleral ring. FIG. 35 shows a contact lens 3500 having a peripheral edge3502 and pupil zone 3510. Pupil zone 3510 may have optical power or maybe devoid of optical power and has a standard thickness and convex curveas that of a conventional contact lens having a specified optical poweror lack thereof. Located between peripheral edge 3502 and pupil zone3510 is an incremental thickness region 3506. It should be pointed outthat the incremental thickness region (aperture widening zone) 3506 canstart at or adjacent to the outer edge of the prosthesis. While a singlering is shown for incremental thickness region 3506 it is appreciatedthat there may be multiple rings or partial rings. Surroundingincremental thickness region 3506 and located between peripheral edge3502 and incremental thickness region 3506 is a peripheral region 3504.Peripheral region 3504 has thickness and curvature equal to the standardthickness and curvature of a conventional contact lens. An internalregion 3508 is located between pupil zone 3510 and incremental thicknessregion 3506. Internal region 3508 has a thickness and curvature equal tothat of a conventional contact lens.

FIG. 36 shows a contact lens 3600 having a peripheral edge 3602 andpupil zone 3610. Pupil zone 3610 may have optical power or may be devoidof optical power and has a standard surface friction, thickness, andconvex curvature as that of a conventional contact lens having aspecified optical power or lack thereof. Located between peripheral edge3602 and pupil zone 3610 is an increased surface friction region 3606.Increased surface friction region 3606 includes a textured surface thatincreases surface friction. The textured surface can be created by, butnot limited to, a different material, dimples, bumps, surfacesirregularities, any change in surface topography, or any combinationthereof. While a single ring is shown for increased surface frictionregion (aperture widening zone) 3606 it is appreciated that there may bemultiple rings. Surrounding increased surface friction region 3606 andlocated between peripheral edge 3602 and increased surface frictionregion 3606 is a peripheral region 3604. Peripheral region 3604 has asurface friction equal to the standard surface friction of aconventional contact lens. An internal region 3608 is located betweenpupil zone 3610 and increased surface friction region 3606. Internalregion 3608 has a surface friction, thickness, and curvature equal tothat of a conventional contact lens.

FIG. 37 shows a contact lens 3700 having a peripheral edge 3702 andpupil zone 3710. Pupil zone 3710 may have optical power or may be devoidof optical power and has a standard surface friction, thickness, andconvex curvature as that of a conventional contact lens having aspecified optical power or lack thereof. Located between peripheral edge3702 and pupil zone 3710 is an incremental thickness and increasedsurface friction region 3706. Incremental thickness and increasedsurface friction region (aperture widening zone) 3706 includes anincreased thickness and textured surface that increase surface friction.The textured surface can be created by, but not limited to, a differentmaterial, surface treatment, dimples, bumps, surfaces irregularities,any change in surface topography, or any combination thereof. While asingle ring is shown for incremental thickness and increased surfacefriction region 3706 it is appreciated that there may be multiple rings.Surrounding incremental thickness and increased surface friction region3706 and located between peripheral edge 3702 and incremental thicknessand increased surface region 3706 is a peripheral region 3704.Peripheral region 3704 has a thickness and surface friction equal to thestandard thickness and surface friction of a conventional contact lens.An internal region 3708 is located between pupil zone 3710 and increasedsurface friction region 3706. Internal region 3708 has a thickness,surface friction, and curvature equal to that of a conventional contactlens.

FIG. 38 shows a contact lens 3800 having a peripheral edge 3802 and apupil zone 3810. Pupil zone 3810 may have optical power or may be devoidof optical power and has a standard thickness and convex curvature asthat of a conventional contact lens having a specified optical power orlack thereof. Pupil zone 3810 can also include an astigmatic opticalpower. Located above and below pupil zone 3810 are two incrementalthickness regions 3806. It should be noted that each of the twoincremental thickness regions 3806 (aperture widening zones) will havean outer slope, inner slope and point of maximum thickness delta/maximumincreased thickness. Each incremental thickness region 3806 has ahemispherical shape. Contact lens 3800 also includes two internalregions 3808 located on either side of pupil zone 3810. Each internalregion 3808 has a thickness and curvature equal to a standard thicknessand curvature of a conventional contact lens. Surrounding the peripheryof the lens is a peripheral region 3804 which also has a thickness andcurvature equal to a standard thickness and curvature of a conventionalcontact lens. However, it should be noted that each of the twoincremental thickness regions could start at or adjacent to the outeredge of the contact lens. It will be appreciated that incrementalthickness regions 3806 can also include a textured surface thatincreases surface friction. Additionally, incremental thickness regions3806 can be replaced with increased surface friction regions having atextured surface and having conventional thickness and curvature.

FIGS. 39A-E illustrates the surface profile of a contact lens 3900according to one embodiment. Contact lens 3900 has an optical power of0.0+/−1.00 D. As seen in FIG. 39A, contact lens 3900 includes a firstsurface 3904, a second surface 3906, third surface 3908, and a fourthsurface 3910. First surface 3904 has a radius of curvature rangingbetween 6.50 mm and 9.5 mm. Second surface 3906 exemplifies anincremental thickness region in the form of a bump (aperture wideningzone). The radius of curvature of second surface 3906 ranges between4.50 mm and 7.50 mm. Second surface 3906 can have a width between 2.0 mmand 4.0 mm. Third surface 3908 has a radius of curvature ranging between6.50 mm and 9.50 mm. Fourth surface 3910 is located on the outer mostperiphery of contact lens 3900 and has a radius of curvature rangingfrom 2.0 mm and 8.0 mm. The overall diameter of contact lens 3900 canrange from 11.0 mm to 16.5 mm. FIG. 39B shows a side view of contactlens 3900. FIG. 39C shows a cross-section of contact lens 3900 alongline 3902 in FIG. 39A. FIG. 39D shows the convex surface of contact lens3900 and FIG. 39E shows the concave surface of contact lens 3900.

FIG. 40 shows a contact lens 4000 having a spherical optical powersuperimposed on an eye 4014. Eye 4014 has an upper lid 4012 and a lowerlid 4008. Contact lens 4000 includes an area of incremental thickness(aperture widening zone) 4002, a pupil zone 4006, and a peripheral edge4004. It can be seen in FIG. 40 that contact lens 4000 has an area 4010that fits under upper lid 4012. Included in area 4010 is part ofincremental thickness region 4002.

FIG. 41 shows a contact lens 4100 having an astigmatic optical powersuperimposed on an eye 4114. Eye 4114 has an upper lid 4112 and a lowerlid 4108. Contact lens 4100 includes an incremental thickness region(aperture widening zone) 4102, a pupil zone 4106, and a peripheral edge4104. It can be seen in FIG. 41 that contact lens 4100 has an area 4110that fits under upper lid 4112. Included in area 4110 is part ofincremental thickness region 4102. Contact lens 4100 also has aweighted/stabilization zone 4116 located on the bottom.

FIG. 42 shows a contact lens 4200 having a spherical optical powersuperimposed on an eye 4214. Eye 4214 has an upper lid 4212 and a lowerlid 4208. Contact lens 4200 includes an incremental thickness region(aperture widening zone) 4218 having a plurality of partial rings 4202,a pupil zone 4206, and a peripheral edge 4204. It can be seen in FIG. 42that contact lens 4200 has an area 4210 that fits under upper lid 4212.Included in area 4210 is a plurality of partial rings 4202 located inincremental thickness region 4218.

FIG. 43 shows a contact lens 4300 having a spherical optical powersuperimposed on an eye 4314. Eye 4314 has an upper lid 4312 and a lowerlid 4308. Contact lens 4300 includes an incremental thickness region(aperture widening zone) 4318 having a plurality of partial rings 4302,a pupil zone 4306, and a peripheral edge 4304. It can be seen in FIG. 43that contact lens 4300 has an area 4310 that fits under upper lid 4312.Included in area 4310 is a plurality of the partial rings 4302 locatedin incremental thickness region 4318. Contact lens 4300 also has aweighted/stabilization zone 4316 located on the bottom.

FIG. 44 shows an embodiment of a hybrid multifocal contact lens 4400.Contact lens 4400 includes a peripheral edge 4402 surrounding a softskirt 4404. Soft skit 4404 includes an incremental thickness region(aperture widening zone) 4406. A junction 4416 is located at theperiphery of incremental thickness region 4406. Junction 4416 connectsincremental thickness region 4406 to a gas permeable rigid zone 4408.Gas permeable rigid zone 4408 has a continuous graduation of power 4412and includes aspheric distance zone 4410 and aspheric near zone 4414.While the embodiment of FIG. 44 shows incremental thickness region 4406located near peripheral edge 4402 it can be located anywhere adjacent toor peripheral to gas permeable rigid zone 4408. By this it is meant thatincremental thickness region 4406 can be located adjacent to or outsideof 3.0 mm of a geometric center of hybrid contact lens 4400.

FIG. 45 shows an embodiment of a hybrid contact lens 4500 superimposedon an eye. Contact lens 4500 includes a peripheral edge 4502 surroundinga soft skirt 4504. Soft skit 4504 includes an incremental thicknessregion 4506 (aperture widening zone) and has a junction 4516 located onits peripheral edge. Junction 4516 connects soft skit 4504 to a gaspermeable rigid zone 4508. Gas permeable rigid zone 4508 can include aspherical optical power or an astigmatic optical power.

FIG. 46 shows an embodiment of a soft multifocal contact lens 4600.Contact lens 4600 includes a peripheral edge 4602, an area ofincremental thickness (aperture widening zone) 4604, a near distancezone 4606 (illustrated as the ring that circles the geometrical centerof the contact lens), an intermediate zone 4608 (illustrated as the ringthat circles the geometrical center of the contact lens), and a distancezone 4610 (illustrated as the larger central dark area which issurrounded by intermediate zone 4608).

FIG. 47 shows an embodiment of a reverse hybrid contact lens 4700.Contact lens 4700 includes a peripheral edge 4702 and a geometric center4712. A rigid outer skirt 4704 surrounds a soft center 4710 and includesan incremental thickness region (aperture widening zone) 4706. Junction4708 is located between rigid outer skit 4704 and soft center 4710.

Patient Selection Process for Fitting the Prosthesis:

The prosthesis provides the significant cosmetic enhancement/widening ofthe palpebral fissure of the wearer's eye when fitted on an eye that hasan upper lid margin within 2 mm to 3 mm or less of the upper edge of thepupil and/or a lower lid margin is within 2 mm to 3 mm or less of thelower edge of the pupil. Another way of establishing patient selectionfor the prosthesis is the selection of any eye where the upper or lowerlid, in a resting location with the lids open, covers the upper and/orlower limbal area of the eye.

The embodiments disclosed herein also teach an instrument that projectsan image of known diameters onto the skin and facial eye region of apotential wearer. The instrument allows for taking a photo of theprojected image on the eye and the adjacent facial region of thepotential wearer. By doing this it is possible to quickly understand theappropriate diameter contact lens or scleral ring needed to provide thebest palpebral widening effect. In some embodiments infrared light isused to project light onto the eye of the wearer so to minimize anyconstriction of the wearer's pupil. In other embodiments low levels ofvisible light are projected. In still other embodiments an infra-redcamera is used.

The process further contemplates a fitting set of the prosthesis wherebyin the case of the contact lens prosthesis a set of rings or series ofdots or lines are painted or affixed to the contact lens; each dot, lineor ring by way of example only being 1 mm less diameter than theoutermost adjacent dot, line or ring. This then allows an eye careprofessional to visually determine quickly when the prosthesis is triedon the eye of the wearer which contact lens provides the maximumaperture widening. The professional can also then simply indicate thenumber of lines or rings present in the open aperture of various triallenses thus allowing selection of the one that presents the greatestnumber of lines or rings within the aperture of the wearer's eye.

In a first fitting method embodiment the following technique is followedin fitting the prosthesis that is taught herein:

#1) Take a photograph of intended wearer's eye or eyes whilepatient/intended wearer is relaxed without smiling;

#2) Display or print photograph;

#3) Measure the natural palpebral fissure or fissures as shown in thedisplayed or printed photograph;

#4) Choose a trial prosthesis that provides good centration and has anoverall outer diameter that is within the range of 1 mm to 10 mm widerthan the palpebral fissure just measured of the intended wearer beingfit, however in most cases it will be 2 mm to 4 mm wider;

#5) Choose a prosthesis to be prescribed and/or delivered to patientafter viewing the appearance of wearer's eye (this can be done solely bythe eye care professional and/or by feedback from the patient beingfit);

#6) Repeat the appropriate steps for fitting the second eye of theintended wearer or patient.

In a Second fitting method embodiment the following technique isfollowed in fitting the prosthesis that is taught herein:

#1) Measure the natural palpebral fissure of the patient's/intendedwearer's eye or eyes while patient/intended wearer is relaxed withoutsmiling;

#2) Choose a trial prosthesis that provides good centration and has anoverall outer diameter that is within the range of 1 mm to 10 mm widerthan the palpebral fissure just measured of the intended wearer beingfit, however in most cases it will be 2 mm to 4 mm wider;

#3) Choose a prosthesis to be prescribed and/or delivered to a patientafter viewing the appearance of wearer's eye (this can be done solely bythe eye care professional and/or by feedback from the patient beingfit);

#4) Repeat the appropriate steps for fitting the second eye of theintended wearer or patient.

In a third fitting method embodiment the following technique is followedin fitting the prosthesis that is taught herein:

#1) Take a photograph of intended wearer's eye or eyes whilepatient/intended wearer is relaxed without smiling;

#2) Display or print photograph;

#3) Measure the natural palpebral fissure or fissures as shown in thedisplayed or printed photograph;

#4) Fit a prosthesis out of inventory or order a prosthesis thatprovides good centration and has an overall outer diameter that iswithin the range of 1 mm to 10 mm wider than the palpebral fissure justmeasured of the intended wearer being fit, however in most cases it willbe 2 mm to 4 mm wider.

In a Fourth fitting method embodiment the following technique isfollowed in fitting the prosthesis that is taught herein:

#1) Measure the natural palpebral fissure of the patient's/intendedwearer's eye or eyes while patient/intended wearer is relaxed withoutsmiling;

#2) Fit a prosthesis out of inventory or order a prosthesis thatprovides good centration and has an overall outer diameter that iswithin the range of 1 mm to 10 mm wider than the palpebral fissure justmeasured of the intended wearer being fit, however in most cases it willbe 2 mm to 4 mm wider.

In a Fifth fitting method embodiment the following technique is followedin fitting the prosthesis that is taught herein:

#1) Fit the prosthesis out of inventory or order a prosthesis thatprovides good centration and has an overall outer diameter that iswithin the range of 1 mm to 10 mm wider than the palpebral fissure justmeasured of the intended wearer being fit, however in most cases it willbe 2 mm to 4 mm wider.

In some embodiments, a method of widening the natural palpebral fissureof an individuals' eye may include measuring the vertical dimension ofthe natural palpebral fissure of an individual's eye. In someembodiments, the measurement of the vertical dimension may be performedwhile the individual in not wearing a prosthesis on his eye (e.g., forpeople who do not normally wear contact lenses). In some embodiments,the measuring of the vertical dimension may be performed while theindividual is wearing his prescribed contact lenses. Measuring thevertical dimension of the natural palpebral fissure may be determinedusing at least one of: taking a photograph of the individual's eye andmeasuring the vertical dimension of the individual's palpebral fissurein the photograph, physically measuring the vertical dimension of theindividual's palpebral fissure, visually estimating the verticaldimension of the individual's palpebral fissure, fitting a trialprosthesis having markings that indicate one or more vertical dimensionson the individual's eye, and fitting a trail prosthesis having a knowndiameter on the individual's eye. These measurements may be performedwhile the individual's eyes are relaxed and the individual is notsmiling.

Before or after measuring, an individual may be provided with aprosthesis comprising an aperture widening zone with a minimum verticaldimension (or aperture widening zone diameter) at least 1 mm greaterthan the individual's natural palpebral fissure. In some embodiments,the minimum vertical dimension (or aperture widening zone diameter) ofthe first prosthesis is chosen based on the vertical dimension of thenatural palpebral fissure of the individual's eye. As a non-limitingexample, a prosthesis with an aperture widening zone having a minimumvertical dimension that is 2 mm or larger than the vertical dimension ofthe natural palpebral fissure of an individual's eye may be selected foran individual having severe ptosis. In some embodiments, the minimumvertical dimension of the first prosthesis is no greater than 1 mmlarger than the vertical dimension of the natural palpebral fissure ofthe individual's eye. In some embodiments, the aperture widening zone ofthe first prosthesis may have a minimum vertical dimension of greaterthan or equal to 8 mm.

In some embodiments, while the individual is wearing the firstprosthesis, the vertical dimension of the eye's palpebral fissure isre-measured using one or more of the measuring processes discussedabove. After re-measuring, it may be determined whether the verticaldimension of the palpebral fissure of the individual's eye has beenwidened by at least 1 mm relative to the measurement performed when theindividual was not wearing a prosthesis (or when the individual waswearing his prescribed contact lens).

In some embodiments, additional prosthesis may be fitting onto anindividual's eye and the vertical dimension of the individual'spalpebral fissure may be re-measured until the individual's naturalpalpebral fissure is widened by at least 1 mm and/or widened by amaximum amount achievable using the additional prostheses. Thesere-measurements may be performed using one or more of the techniquesdiscussed above. Moreover, additional prosthesis may be fitted onto anindividual's eye to determine the prosthesis that is most comfortablefor the individual, while also widening the individual's naturalpalpebral fissure.

In some embodiments, an individual or third party may perform one ormore of the above actions by following a set of instructions. In someembodiments, the instructions may serve to aid an individual indetermining which prosthesis from a set of prosthesis is optimal for himor her (e.g., which prosthesis widens his or her natural palpebralfissure the most). In some embodiments, the instructions may be providedwith various prosthesis having various aperture widening zone designs soan individual can try various prostheses to determine which prosthesismost effectively widens his or her natural palpebral fissure (e.g., atrial kit of prostheses). In some embodiments, a prosthesis having anaperture widening zone with a minimum vertical dimension at least 1 mmgreater than the individual's natural palpebral fissure can be providedto the individual after following the instructions.

In some embodiments, the method includes providing to the individual aprosthesis that, when worn, results in the individual having a palpebralfissure with a minimum vertical dimension (or aperture widening zonediameter) at least 1 mm greater than the vertical dimension of theindividual's natural palpebral fissure. The prosthesis may be providedwithout any measurements or instructions. In such a case, the prosthesismay be provided based on general characteristics of an individual (e.g.,age, race, medical conditions, sex, etc.).

FIG. 48 shows an example of a method for fitting a prosthesis asdescribed herein. As seen in FIG. 48, an image 4800 is projected onto anindividual's eye. Image 4800 includes a scale 4802 with a plurality ofmarkings 4804. Marking 4804 are used to measure the individual'spalpebral fissure and used to determine the diameter of a prosthesisthat will raise the upper lid, or depress the lower lid, therebywidening the individual's palpebral fissure.

It should be understood that any and all known contact lens treatments,colors, custom color designs (including color designs, such as by way ofexample only a limbal ring, color ring, or colored accent, imparted onthe prosthesis to increase the appearance of the size of the outerlimbus thus making the wearer's eye appear larger), coatings, materials,filtering of specific wavelength (lengths) of light, contact lensdesigns, shapes, optical powers including piano, static or dynamicfocusing contact lenses, any known optical powers required forastigmatic, spherical, and presbyopic correction can be considered toapply to the prosthesis (contact lens or scleral ring) described herein.By way of example only when the prosthesis is in the form of a contactlens the contact lens can be; single vision with spherical only opticalpower, single vision with sphero-cylinder optical power, multifocal withspherical only optical power, multifocal with sphero-cylinder opticalpower. A prosthesis in the form of a scleral ring would not have opticalpower and will not be considered single vision or multifocal.

It should be understood that the embodiments as disclosed herein coverany means by which a soft contact lens or hybrid contact lens or scleralring increases the size of the wearer's palpebral fissure by way of “oneor more” of the following features of the contact lens, by way ofexample only; “incremental thickness region (aperture widening zone)”,increased overall thickness, increased edge thickness, increased overalldiameter, localized area of increased thickness, increased convexsurface friction, localized area of increased convex surface friction,increased partial area of raised thickness on convex surface, regressivethickness zone, convex surface treatment (material and/or texture),truncation to superior edge of lens, truncation to the inferior edge ofthe lens, truncation to the superior and inferior edge of the lens,increased thickness of the edge of the lens, (partial or complete) band(bands) or ring (rings), dome (domes), segment (segments) of increasedthickness on the convex surface of the contact lens external to thepupil zone, and increased base curve fit. This list is not intended tobe limiting.

It should be understood that while some embodiments herein have beendescribed in reference to the convex surface of a prosthesis having anaperture widening zone with increased and/or regressive thickness, theaperture widening zones described herein may be placed on the concavesurface of the prosthesis. If the prosthesis is made with a sufficientlyflexible material, an increased and/or regressive thickness (i.e.,thickness delta) located on the concave surface of the prosthesis willbehave the same as or similar to as if it were located on the convexsurface.

In some, but not all, embodiments the prosthesis has an increasedthickness region superior to the pupil zone.

In some, but not all, embodiments the prosthesis has an increasedthickness region inferior to the pupil zone.

In some, but not all, embodiments the prosthesis has an increasedthickness region superior and inferior to the pupil zone.

In some, but not all, embodiments the prosthesis provides truncationand/or weighting to stabilize the prosthesis.

In some, but not all, embodiments the lens edge is that of aconventional prosthesis thickness and edge.

In some, but not all embodiments, the lens edge has a thicker overallthickness and edge compared to traditional contact lenses.

It is important to note that the increased thickness of the contact lensprosthesis (whether within the pupil zone or external to the pupil zone)in most, but not all embodiments, does not alter the desiredprescription or optical power of the portion of the contact lens thatfocuses light on the retina of the wearer of the contact lens.

In some embodiments one of a soft or hybrid contact lens is of sphericaloptical power, however the area peripheral to the pupilary zone isconfigured like that of a minus aspheric toric lens having an axis of180 (+/−20 degrees) in terms of thickness, meaning the thickness aboveand below the pupilary zone is thicker than normal.

In other embodiments one of a soft or hybrid contact lens is ofspherical optical power, however the area peripheral to the pupilaryzone is configured like that of one of a soft or hybrid contact lens interms of thickness, with the exception of this peripheral area being ofincreased thickness compared to that of a conventional/traditional softor hybrid spherical power contact lens for the same optical power,diameter and base curve.

In some embodiments one of a soft or hybrid contact lens comprisesastigmatic optical power, and the area peripheral to the pupilary zoneis configured like that of a minus aspheric toric lens having an axis of180 (+/−20 degrees) in terms of thickness, meaning the thickness “aboveand below” the pupilary zone is thicker than normal for a typicalastigmatic correcting soft or hybrid contact lens.

Some embodiments contemplate spherical lenses with no optical power axisbeing such that the area superior and inferior to the pupil zone of thesoft contact lens or hybrid contact lens is thicker than would beexpected for a soft or hybrid contact lens having such a spherical orastigmatic optical power.

Some embodiments contemplate astigmatic lenses having an optical axisbeing such that the area superior and inferior to the pupil zone of thesoft contact lens or hybrid contact lens is thicker than would beexpected for a soft or hybrid contact lens having such a spherical orastigmatic optical power.

Some embodiments contemplate an incremental thickness region (zone,area) or a regressive thickness region (zone, area) located on theconvex surface of the prosthesis that is rotationally symmetrical.

Some embodiments contemplate an incremental thickness region (zone,area) or a regressive thickness region (zone, area) located on theconvex surface of the prosthesis that is rotationally asymmetrical.

Some embodiments contemplate an incremental thickness region (zone,area) or a regressive thickness region (zone, area) located on theconvex surface of the prosthesis that is non-rotationally symmetrical.

Some embodiments contemplate an incremental thickness region (zone,area) or a regressive thickness region (zone, area) located on theconvex surface of the prosthesis that approximates the curve of theupper lid margin and/or the curve of the lower lid margin.

The incremental thickness region (aperture widening zone) of theprosthesis can have a maximum delta thickness differential (addedthickness) within the range of 25 microns to 1,000 microns, with apreferred range of 100 microns to 500 microns, with a more preferredrange of 75 microns to 400 microns.

The regressive thickness region (aperture widening zone) of theprosthesis can have a maximum delta thickness differential (reducedthickness) within the range of 25 microns to 1,000 microns, with apreferred range of 100 microns to 500 microns, with a more preferredrange of 100 microns to 400 microns, with a more preferred range of 75microns to 400 microns.

The convex surface region of incremental thickness (aperture wideningzone) of the prosthesis can be located within the range of 3 mm to 8.5mm from the geometrical center of the contact lens, and more preferablywithin 5 mm to 7.75 mm from the geometrical center of the contact lens.

The region of incremental thickness or regressive thickness (aperturewidening zone) is in most cases internal to the edge of the prosthesis.However in some cases, not most, it can start at the outer edge of theprosthesis.

The delta of maximum incremental thickness in most cases is within 0.5mm to 3.0 mm internal to the edge of the prosthesis.

The delta of maximum incremental thickness in most (but not all) casesis within 0.5 mm to 3.0 mm internal to the edge of the prosthesis. Butthis may depend upon the overall diameter dimension and that of thedelta of incremental thickness dimension.

The incremental thickness region (zone, area) (aperture widening zone)is in most cases within 0.1 mm to 6.0 mm internal to the outer edge ofthe prosthesis.

The incremental thickness region (zone, area) (aperture widening zone)in some cases can start at the outer edge of the prosthesis and proceedto 6 mm internal to the outer edge of the prosthesis.

The regressive thickness region (zone, area) (aperture widening zone) isin most cases within 0.1 mm to 6.0 mm internal to the edge of theprosthesis. However in some cases, not most, it can start at the outeredge of the prosthesis.

The width of the incremental thickness region (zone, area) (aperturewidening zone) or the regressive thickness region (zone, are) (aperturewidening zone) can be 0.5 mm to 6 mm.

The incremental thickness diameter and the regressive thickness diametermay fall within the range of 7 mm to 15 mm.

In some embodiments there are multiple rings or zones of incrementalthickness and or regressive thickness; whereby one ring is locatedinterior to another ring (or closer to the geometrical center of thelens).

In some embodiments, the region or zone of incremental thickness(aperture widening zone) has a slope and a delta of maximum thickness,whereby the outer slope on the outside of the delta of maximumincremental thickness (closer to the outer edge of the prosthesis) issteeper than the inner slope on the inside (closest to the center of theprosthesis).

In some embodiments, the region or zone of regressive thickness has anouter slope and a delta of maximum regressive thickness, whereby theinner slope on the side of the delta of maximum regressive thickness(closer to the center of the prosthesis) is the steepest.

In some embodiments, the region or zone of regressive thickness has anouter slope and a delta of maximum regressive thickness, whereby theinner slope on the side of the delta of maximum regressive thickness(closer to the center of the prosthesis) is equal to the outer slope.

In some embodiments, the prosthesis in the form of a contact lens orscleral ring can comprise finger like members that fold towards thecenter of the scleral ring when the eye lid closes or blinks and opensaway (unfolds) from the center of the scleral ring when the eye lid isopened. The finger like members can be located on the region of thescleral ring above and below the pupil of the eye. The finger likemembers can elevate the upper lid and depress or lower the lower lidwhen the eye lid is open and not blinking or closed.

When the term contact lens is provided or used in this disclosure it ismeant to be that of one of: a corneo-scleral contact lens or hybridcontact lens.

When the term incremental thickness region is used it is meant to be theaperture widening zone.

When the term regressive thickness region is used it is meant to be theaperture widening zone.

When the term increased surface friction region is used it is mean to bethe aperture widening zone.

In some embodiments of the prosthesis there may or may not be anincremental thickness zone (region, area), or a regressive thicknesszone (region, area) but rather the surface of the zone or region isaltered to provide increased lid friction compared to other areas of theprosthesis. This region or zone of increased surface friction can beeasily over come during an eye lid blink or forced closure but uponopening the eye lid this region of increased friction elevates the upperlid and/or depresses the lower lid thus opening the aperture of the eye.

The prosthesis disclosed herein can be stabilized (by the use of astabilization zone) to prevent rotation in the case, by example only, ofa multifocal or a toric single vision lens or a toric multifocal.

The prosthesis disclosed herein can be devoid of stabilization (notstabilized/free to rotate) in the case, by example only, of a singlevision spherical lens.

The prosthesis disclosed herein can be free to rotate uponnatural/normal blinking of the eyes always when in the form of a scleralring. And also in most (but not all embodiments) when in the form of asingle vision contact lens comprising solely spherical optical power anddevoid of a stabilization zone, feature or member.

The prosthesis in some embodiments disclosed herein is not free torotate upon natural/normal blinking of the eyes always when in the formof a scleral ring.

In some embodiments the aperture widening zone and the stabilizationzone can be one and the same by design. In other embodiments theaperture widening zone is separate from the stabilization zone, featureor member.

FIGS. 49-53 illustrate exemplary embodiments of a prosthesis having anaperture widening zone. FIG. 49 shows a scleral ring 4900 having anaperture widening zone 4906 spaced apart from its peripheral edge 4902.Located between peripheral edge 4902 and aperture widening zone 4906 isa first region 4904. First region 4904 has a thickness and curvatureequal to that of a conventional scleral ring. Aperture widening zone4906 has an outer edge 4908 and an inner edge 4916. Aperture wideningzone 4906 has an incremental thickness defined by an outer slope 4910and an inner slope 4914 with a maximum incremental thickness 4912located between outer slope 4910 and inner slope 4914. A second region4918 is located adjacent to inner edge 4916 and extends towards an opencentral aperture 4920. Similar to first region 4904, second region 4918has a thickness and curvature equal to that of a conventional scleralring. Located in the center of open central aperture 4920 is thegeometric center 4922 of scleral ring 4900. FIG. 49 also shows thevertical dimension (VD) of scleral ring 4900. The vertical dimension(VD) being measured from the upper most point of outer edge 4908 to thelower most point of outer edge 4908.

FIG. 50 shows a scleral ring 5000 having an aperture widening zone 5004beginning at its peripheral edge 5002. Aperture widening zone 5004 hasan incremental thickness defined by an outer slope 5006 and an innerslope 5010 with a maximum incremental thickness 5008 located betweenouter slope 5006 and inner slope 5010. Aperture widening zone 5004includes an inner edge 5012 adjacent to an open central aperture 5014.Located in the center of open central aperture 5014 is the geometriccenter 5016 of scleral ring 5000. FIG. 50 also shows the verticaldimension (VD) of scleral ring 5000. The vertical dimension (VD) beingmeasured from the upper most part of peripheral edge 5002 to the lowermost part of peripheral edge 5002.

FIG. 51 shows a contact lens 5100 having an aperture widening zone 5106spaced apart from its peripheral edge 5102. Located between peripheraledge 5102 and aperture widening zone 5106 is a first region 5104. Firstregion 5104 has a thickness and curvature equal to that of aconventional contact lens. Aperture widening zone 5106 has an outer edge5108 and an inner edge 5116. Aperture widening zone 5106 has anincremental thickness defined by an outer slope 5110 and an inner slope5114 with a maximum incremental thickness 5112 located between outerslope 5110 and inner slope 5114. A second region 5118 is locatedadjacent to inner edge 5116 and extends towards the geometrical center5120 of the contact lens 5100. Second region 5118 can have an opticalpower or can be devoid of optical power and has a thickness andcurvature equal to that of a conventional contact lens having a specificoptical power or lack thereof. FIG. 51 also shows the vertical dimension(VD) of contact lens 5100. The vertical dimension (VD) being measuredfrom the upper most part of outer edge 5108 to the lower most part ofouter edge 5108.

FIG. 52 shows a contact lens 5200 having an aperture widening zone 5204beginning at its peripheral edge 5202. Aperture widening zone 5204 hasan incremental thickness defined by an outer slope 5206 and an innerslope 5210 with a maximum incremental thickness 5208 located betweenouter slope 5206 and inner slope 5210. A second region 5214 is locatedadjacent to an inner edge 5212 of aperture widening zone 5204 andextends towards the geometric center 5216 of the contact lens 5200.Second region 5214 can have an optical power or can be devoid of opticalpower and has a thickness and curvature equal to that of a conventionalcontact lens having a specific optical power or lack thereof. FIG. 52also shows the vertical dimension (VD) of contact lens 5200. Thevertical dimension (VD) being measured from the upper most part ofperipheral edge 5202 to the lower most part of peripheral edge 5202.

FIGS. 53A-E show various exemplary embodiments of aperture wideningzones having a plurality of bands of incremental thickness 5304. Thebands of incremental thickness are arranged in a spoke-like fashionaround either an open central aperture 5300 or an optic zone 5302. Whilea plurality of different patterns are shown in FIGS. 53A-E it isappreciated that any number or orientation of bands of incrementalthickness 5304 can be present in the aperture widening zone.

FIGS. 54-56 illustrate the palpebral fissure widening effect of anaperture widening zone described herein. FIG. 54 shows an individual'snatural palpebral fissure. As seen in FIG. 54 the maximum diameter ofthe individual's left natural palpebral fissure (right side of FIG. 54)is approximately 6 mm. FIG. 55 shows the same individual wearing aprosthesis having an aperture widening zone as described herein. It canbe seen from FIG. 55 that the palpebral fissure of his left eye has beenwidened. The maximum diameter of his left eye's palpebral fissure is nowapproximately 9.5 mm, an increase of approximately 3.5 mm. FIG. 56 showsthe left eye in FIGS. 54 and 55 side by side for comparison.

FIGS. 57-60 show various graphs exemplifying the surface profile ofembodiments of the prosthesis as described herein. FIGS. 57-60 quantifythe inner and outer slopes of various aperture widening zones. FIGS. 57and 58 show prostheses having a maximum change in thickness locatedapproximately 5.7 mm from the geometrical center of the prostheses. FIG.59 shows a prosthesis having a maximum change in thickness locatedapproximately 5.3 mm from the geometrical center of the prosthesis. FIG.60 shows a prosthesis having a maximum change in thickness locatedapproximately 5.55 mm from the geometrical center of the prosthesis.

FIG. 61 illustrates the dimensions of a contact lens 6130 compared tothe anatomy of a human eye. The human eye has an upper lid 6120, a lowerlid 6122, a cornea 6124, and a sclera 6128. Located at the interface ofcornea 6214 and sclera 6128 is a limbus 6126. In other words, limbus6126 is located adjacent to the outer peripheral edge of cornea 6214 andadjacent to sclera 6128. The average diameter of the cornea is11.71+/−0.42 mm. The average corneal diameter is 11.77+/−0.37 mm inmales compared with 11.64+/−0.47 mm in females.

Contact lens 6130 having an aperture widening zone 6132 is shown asbeing worn on the eye and extends across cornea 6124 and limbus 6126 tosclera 6128 on both sides of cornea 6124. A visual representation 6100of contact lens 6130 is shown to the left of the eye (this is not theactual lens, but rather a representation showing the various dimensionsof contact lens 6130). As shown by visual representation 6100, contactlens 6130 has an aperture widening zone 6132 located adjacent to aperipheral edge 6102. Aperture widening zone 6132 is defined by an outerslope 6104, a maximum incremental thickness 6106, an inner slope 6108,and an inner edge 6110. Located inside of inner edge 6110 is an opticalpower zone 6112 with a geometric center 6114 located therein. It can beseen from FIG. 61 that maximum incremental thickness 6106 is locatedoutside of limbus 6126 on both sides of the eye.

FIG. 62 illustrates the dimensions of a scleral ring 6230 compared tothe anatomy of a human eye. The human eye has an upper lid 6220, a lowerlid 6222, a cornea 6224, and a sclera 6228. Located at the interface ofcornea 6214 and sclera 6228 is a limbus 6226. Scleral ring 6230 havingan aperture widening zone 6232 is shown as being worn on the eye andextends across cornea 6224 and limbus 6226 to sclera 6228 on both sidesof cornea 6224. A visual representation 6200 of scleral ring 6230 isshown to the left of the eye (this is not the actual lens, but rather arepresentation showing the various dimensions of scleral ring 6130). Asshown by visual representation 6200, scleral ring 6230 has an aperturewidening zone 6232 located adjacent to a peripheral edge 6202. Aperturewidening zone 6232 is defined by an outer slope 6204, a maximumincremental thickness 6206, an inner slope 6208, and an inner edge 6210.Located inside of inner edge 6210 is an open central aperture 6212 witha geometric center 6214 located therein. It can be seen from FIG. 62that maximum incremental thickness 6206 is located outside of limbus6226 on both sides of the eye.

FIGS. 63A-66D illustrate examples of how to measure the verticaldimension and/or the minimum vertical dimension for various shapes.While these figures are simplified versions of exemplary shapes ofaperture widening zones it is appreciated that any shape will have avertical dimension and a minimum vertical dimension. For purposes ofthese illustrations it will be assumed that the points used to measurevertical dimensions and/or minimum vertical dimensions would be locatedon the upper most part of an aperture widening zone and the lower mostpart of an aperture widening zone.

FIG. 63A shows a prosthesis 6300 having an aperture widening zone withan outer edge 6306 in the shape of a circle. The upper most point ofouter edge 6306 is shown at point 6302 and the lower most point of outeredge 6306 is shown at point 6304. The vertical dimension (VD), measuredfrom upper most point 6302 to lower most point 6304 and projected onto avertical axis, is shown on the left side of FIG. 63A. Because outer edge6306 is in the shape of a circle the vertical dimension (VD) is equal tothe minimum vertical dimension (MVD). For a circle, this is true for anyrotational orientation of the prosthesis.

FIG. 63B shows a prosthesis 6350 having an aperture widening zone withan outer edge 6356 in the shape of an equilateral triangle. The uppermost point of outer edge 6356 is shown at point 6352 and the lower mostpoint of outer edge 6356 is shown at point 6354. The vertical dimension(VD), measured from upper most point 6352 to lower most point 6354 andprojected onto a vertical axis, is shown on the left side of FIG. 63B.In FIG. 63B this is the height of the equilateral triangle which is alsothe minimum vertical dimension (MVD). Because outer edge 6356 is in theshape of an equilateral triangle the vertical dimension will changebased on the orientation of the lens. For example, as shown in FIG. 63C,if the triangle were turned on its side the upper most point would bepoint 6358 and the lower most point would be point 6360. The verticaldimension (VD), measured from point 6358 to point 6360 and projectedonto a vertical axis, is shown on the left side of FIG. 63C. Thisrotational orientation of the triangle results in a larger verticaldimension. This larger vertical dimension results from the fact that allequilateral triangles have a height that is less than the length oftheir sides.

FIGS. 64A-C illustrate how to measure a vertical dimension (VD) and theminimum vertical dimension (MVD) of an aperture widening zone located ona prosthesis 6400 having an outer edge 6420 in the shape of an oval.FIG. 64A shows prosthesis 6400 in a first rotational orientation wherethe oval is positioned such that its minor axis is oriented in thevertical direction. The orientation in FIG. 64A shows a verticaldimension equal to minimum vertical dimension (MVD) for the oval. Theminimum vertical dimension (MVD) is measured from upper most point 6402to lower most point 6404 and projected onto a vertical axis. FIGS. 64Band C show other orientations of the oval where its vertical dimension(VD) is not its minimum vertical dimension. For example, in FIG. 64B theoval's major axis is oriented in the vertical direction. This results ina vertical dimension (VD), measured from point 6410 to point 6412, thatis larger than the oval's minimum vertical dimension (MVD) shown in FIG.64A. Similarly, the orientation of the oval in FIG. 64C shows a verticaldimension (VD), measured from point 6406 to point 6408, that is greaterthan the minimum vertical dimension (MVD) shown in FIG. 64A.

FIGS. 65A-B show another example of how to measure a vertical dimension(VD) and the minimum vertical dimension (MVD) of an aperture wideningzone on a prosthesis 6500 defined by two partial rings having outeredges 6510. FIG. 65A shows an orientation of the prosthesis where thevertical dimension (VD) is equal to the minimum vertical dimension (MVD)for the aperture widening zone. The minimum vertical dimension (MVD)being measured from upper most point 6502 to lower most point 6504. FIG.65B shows an orientation of prosthesis 6500 where the vertical dimension(VD) is not the minimum vertical dimension (MVD). The vertical dimension(VD) in FIG. 65B is measured from upper most point 6506 to lower mostpoint 6508 and is larger than the minimum vertical dimension shown inFIG. 65A.

FIGS. 66A-B illustrate how to measure a vertical dimension and theminimum vertical dimension of an aperture widening zone on a prosthesis6600 defined by a plurality of isolated areas with outer edges 6610arranged in the shape of a square. FIG. 66A shows a first orientation ofprosthesis 6600 where the vertical dimension (VD) for the aperturewidening zone is equal to the minimum vertical dimension (MVD). Outeredges 6610 have points 6602, 6604, 6606, and 6608 which are locatedfurthest from the center of prosthesis 6600. In FIG. 66A, the minimumvertical dimension (MVD) is measured from an upper most point 6602 to alower most point 6606 and projected onto a vertical axis located on theleft of FIG. 66A. FIG. 66B shows a second orientation of prosthesis 6600illustrating a vertical dimension (VD) that is not the minimum verticaldimension (MVD). The vertical dimension (VD) in FIG. 66B is measuredfrom upper most point 6604 to lower most point 6606 and projected onto avertical axis shown on the left side of FIG. 66B. It can be seen thatthe vertical dimension (VD) in FIG. 66B is larger than the minimumvertical dimension (MVD) shown in FIG. 66A.

FIGS. 66C-D illustrate how to measure a vertical dimension and theminimum vertical dimension of an aperture widening zone on a prosthesis6650 defined by a plurality of isolated areas with outer edges 6660arranged in the shape of a triangle. FIG. 66C shows a first orientationof prosthesis 6650 wherein the vertical dimension (VD) is the distancebetween upper most point 6652 and lower most point 6654. FIG. 66D showsa second orientation wherein the vertical dimension is equal to theminimum vertical dimension (MVD). As shown in FIG. 66D the minimumvertical dimension (MVD), measured from upper most point 6654 to lowermost point 6656, is projected onto a vertical axis to the left of FIG.66D.

FIG. 67 shows a scleral ring 6700 having a peripheral edge 6710 and anopen aperture 6702. Located above open aperture 6702 is an incrementalthickness region having an upper finger member 6704 and located belowopen aperture 6702 is an incremental thickness region having a lowerfinger member 6706. Scleral ring 6700 can also have trenches 6708designed to receive finger members 6704 and 6706 when they are foldeddown by the eyelids of a wearer. Trenches 6708 are located adjacent tothe inside of finger members 6704 and 6706. It should be noted thattrenches 6808 are optional.

FIG. 68 shows a contact lens 6800 having a peripheral edge 6810 and anoptic zone 6802. Located above optic zone 6802 is an incrementalthickness region having an upper finger member 6804 and located belowoptic zone 6802 is an incremental thickness region having a lower fingermember 6806. Contact lens 6800 can also have trenches 6808 designed toreceive finger members 6804 and 6806 when they are folded down by theeyelids of a wearer. Trenches 6808 are located adjacent to the inside offinger members 6804 and 6806. It should be noted that trenches 6808 areoptional.

FIG. 69 shows a side view of a contact lens 6900 having an optical zone6902, an upper finger member 6910 and a lower finger member 6908. InFIG. 69 an upper eyelid 6906 is shown in contact with upper fingermember 6910. Upper finger member 6910 lifts (elevates) upper eyelid 6906when contact lens 6900 is worn. FIG. 69 also shows a lower eyelid 6904in contact with lower finger member 6908. Lower finger member 6909depresses (lowers) lower eyelid 6904 when contact lens 6900 is worn.While a contact lens is shown in FIG. 69 it will be appreciated that ascleral ring with finger members (see above description with respect toFIG. 67) would also be capable of lifting (elevating) and/or depressing(lowering) the upper and lower eyelids in the same way as described inFIG. 69.

Table 2 summarizes the effects that four different exemplarilyprostheses had on different individual's eyes.

TABLE 2 Aperture Widening Results for Four different example lenses (I,J, K, and L) Test Embodiment Contact Lenses that showed best % wideningfor Age Gender widening of palpebral fissure best lens(es) 44 Female L~15% 16 Female L, J ~20% 40 Female I, J, L ~10% 33 Male I, J, K ~15% 45Female J, K, L ~18% 25 Female I, J, K, L ~15% 30 Female I, J, K, L ~15%20 Female K ~33% 33 Male K  ~6% 66 Male L ~40%

The specifications for lens I are as follows:

8.4 base curve/15.0 mm overall diameter/150 microns max thickness deltabump 1.0 mm-1.50 mm in from outer edge of the lens/aperture wideningzone begins at the outer edge of the lens/general base thickness(excluding bump & outer edge) within the range of approximately 125microns-175 microns/optical power equals −0.50 D

The specifications for lens J are as follows:

8.4 base curve/15.0 mm overall diameter/300 microns max thickness deltabump 1.5 mm-2.0 mm in from outer edge of the lens/aperture widening zonebegins at the outer edge of the lens/general base thickness (excludingbump & outer edge) within the range of approximately 125 microns-175micron/optical power equals −0.50 D

The specifications for lens K are as follows:

8.4 base curve/15.5 mm overall diameter/150 microns max thickness deltabump 1.0 mm-1.5 mm in from outer edge of the lens/aperture widening zonebegins at the outer edge of the lens/general base thickness (excludingbump & outer edge) within the range of approximately 125 microns-175microns/optical power equals −0.50 D

The specifications for lens L are as follows

8.4 base curve/15.5 mm overall diameter/300 microns max thickness deltabump at 1.5 mm-2.0 mm in from the outer edge of the lens/aperturewidening zone begins at the outer edge of the lens/general basethickness (excluding bump & outer edge) within the range ofapproximately 125 microns-175 microns/optical power equals −0.50 D

Table 2 illustrates that specific lens work best for differentindividuals and that most individual's palpebral fissure can be widenedby wearing a prosthesis comprising an aperture widening zone asdescribed herein. It is appreciated that Table 2 is only an example ofvarious lenses that can be worn and is not meant to limit the dimensionsand/or widening capacities of prostheses described herein.

Some embodiments include a prosthesis capable of being worn by a wearercomprising an aperture widening zone located on its convex outersurface. The prosthesis has an overall diameter of X mm, and thewearer's eye comprises a vertical aperture measurement of Y mm, wherebyX mm is at least 1 mm longer than Y mm. The aperture widening zonewidens the palpebral fissure of the eye of a wearer.

In some embodiments the aperture widening zone depresses (lowers) thelower lid of a wearer. In some embodiments the aperture widening zonelifts (elevates) the upper lid of a wearer. In some embodiments theaperture widening zone lifts (elevates) the upper lid by at least 1 mm.In some embodiments the aperture widening zone depresses (lowers) thelower lid by at least 1 mm. In some embodiments the aperture wideningzone elevates the upper lid by less than 1 mm and/or depresses the lowerlid by less than 1 mm but widens the palpebral fissure of the wearer'seye by at least 1 mm.

The prosthesis comprises a material that is one of: hydrogel, siliconehydrogel, silicon, gas perm, hydrophilic, rigid and flexible.

In some embodiments the prosthesis that is corneo-scleral contact lens.In some embodiments the prosthesis is a soft contact lens. In someembodiments the prosthesis is a hybrid contact lens. In some embodimentsthe prosthesis is a scleral ring.

In some embodiments the aperture widening zone is located internal tothe edge of the prosthesis. In some embodiments the aperture wideningzone begins at the outer edge of the prosthesis.

In some embodiments the aperture widening zone is rotationallysymmetric. In some embodiments the aperture widening zone isrotationally asymmetric.

In some embodiments the aperture widening zone has a maximum incrementalthickness delta that is within the range of 25 microns and 1,000microns. In some embodiments the aperture widening zone has a maximumincremental thickness delta that is within the range of 100 microns and400 microns.

In some embodiments the aperture widening zone is located within a rangeof 3 mm and 8.5 mm from a geometrical center of the prosthesis. In someembodiments the aperture widening zone is located within a range of 5 mmand 7.75 mm from a geometrical center of the prosthesis.

In some embodiments the aperture widening zone is located within a rangeof 0.1 mm to 6.0 mm from an outer peripheral edge of the prosthesis. Insome embodiments the aperture widening zone is located within a rangefrom an outer peripheral edge of the prosthesis to 6.0 mm from the outerperipheral edge of the prosthesis.

In some embodiments the aperture widening zone has a maximum deltathickness located within a range of 0.5 mm to 3.0 mm from an outerperipheral edge of the prosthesis.

In some embodiments the aperture widening zone comprises a bump on theconvex surface of the lens.

The scleral ring in some embodiments comprises an open central aperture.In some embodiments the scleral ring comprises a homogenous design. Insome embodiments the scleral ring comprises a hybrid design.

In some embodiments the scleral ring comprises a flexible finger likemember. In some embodiments the finger like member folds upon the blinkof an eye in a direction towards the geometrical center of the scleralring. In some embodiments the finger like member unfolds upon theopening of the eye lid in a direction away from the geometrical centerof the scleral ring.

The prosthesis can be worn for a time of one of: continuously, daily,weekly and monthly.

In some embodiments the prosthesis is disposable. In some embodimentsthe prosthesis is reusable.

In some embodiments the prosthesis comprises an optical power. In someembodiments the prosthesis is devoid of optical power.

In some embodiments the aperture widening zone has a slope and a deltaof maximum incremental thickness. In some embodiments the slope on theoutside of the delta of maximum incremental thickness (closest to theouter edge of the prosthesis) is steeper than the slope on the inside(closest to the center of the prosthesis).

In some embodiments the prosthesis comprises a zone or region ofincreased surface friction. In some embodiments the prosthesis is devoidof a zone of incremental thickness or regressive thickness, but ratherhas a zone of increased surface friction located on its outer convexsurface.

In some embodiments the width of the aperture widening zone is withinthe range of 0.5 mm to 6 mm.

In some embodiments the outer edge of the prosthesis approximates theedge of a conventional corneo-scleral contact lens.

In some embodiments the aperture widening zone that has a peak deltathickness which corresponds to a point located 0.1 mm or greater abovethe upper lid margin of the wearer when not wearing the prosthesis. Insome embodiments the aperture widening zone that has a peak deltathickness which corresponds to a point located 0.1 mm or more below thelower lid margin of the wearer when not wearing the prosthesis. In someembodiments the peak delta thickness corresponds to a point locatedwithin the natural aperture of the wearer's eye. In some embodiments thepeak delta thickness corresponds to a point located outside the naturalaperture of the wearer's eye (meaning the distance of peak deltathickness to peak delta thickness measured thru the geometrical centerof the prosthesis is larger than the vertical measurement between theupper lid margin and the lower lid margin (the vertical eye aperture).

In some embodiments the aperture widening zone has a diameter (not thewidth of the aperture widening zone) that falls within the range of 7 mmto 15 mm.

In some embodiments the prosthesis is a corneo-scleral contact lens. Insome embodiments the corneo-scleral contact lens is a spherical singlevision contact lens. In some embodiments the corneo-scleral contact lensis a multifocal contact lens. In some embodiments the corneo-scleralcontact lens has a toric optical power. In some embodiments thecorneo-scleral contact lens is a single vision sphero-cylinder contactlens.

In some embodiments the prosthesis comprises a rotationally symmetricaperture widening zone and is not stabilized. In some embodiments theprosthesis comprises a rotationally symmetric aperture widening zone andthe prosthesis is devoid of a stabilization zone.

In some embodiments the prosthesis is devoid of a stabilization zone andthus free to rotate. In some embodiments the prosthesis is stabilizedand thus not free to rotate.

In some embodiments the prosthesis has an aperture widening zone and aseparate aperture stabilization zone.

In some embodiments the prosthesis has an aperture widening zone and theprosthesis is free to rotate during natural blinking.

In some embodiments the prosthesis comprises a colored area which addsto the cosmetic appearance of a larger eye when worn on the eye of awearer. In some embodiments the colored area is one of: a limbal ring,colored ring, or accent color.

In some embodiments the aperture widening zone is located above andbelow the geometrical center along an imaginary vertical axis whichcrosses the geometrical center of the prosthesis

In some embodiments the prosthesis comprises an aperture widening zonelocated to the right or left of the geometrical center along animaginary vertical axis which crosses the geometrical center of theprosthesis.

Some embodiments include a prosthesis for a wearer's eye having anoverall diameter of X mm, and the wearer's eye having a verticalaperture measurement of Y mm, wherein X mm is at least 1 mm longer thanY mm. The prosthesis has an aperture widening zone with an outer slopewithin the range of 3 degrees to 45 degrees.

Some embodiments include a prosthesis for a wearer's eye having anoverall diameter of X mm, and the wearer's eye having a verticalaperture measurement of Y mm, wherein X mm is at least 1 mm longer thanY mm. The prosthesis has an aperture widening zone with an inner slopewithin the range of 1 degree to 15 degrees.

Some embodiments include a prosthesis having an aperture widening zonelocated superior and inferior to its geometrical center. The aperturewidening zone has a thickness slope. The thickness slope exceeding 50microns of added thickness per millimeter

Some embodiments include a prosthesis having an aperture widening zoneon its convex surface. The aperture widening zone causing a bump on theconvex surface. The aperture widening zone has an outer slope thicknessthat is greater than 50 microns of added thickness per mm.

Some embodiments include a prosthesis having an aperture widening zoneon its convex surface. The aperture widening zone causing a bump on theconvex surface. The aperture widening zone has an inner slope thicknessthat is less than 50 microns of added thickness per mm.

In some embodiments the outer slope thickness of the aperture wideningzone is greater than 100 microns of added thickness per mm. In someembodiments the outer slope thickness of the aperture widening zone isgreater than 150 microns of added thickness per mm. In some embodimentsthe outer slope thickness of the aperture widening zone is greater than200 microns of added thickness per mm. In some embodiments the outerslope thickness of the aperture widening zone is greater than 300microns of added thickness per mm.

In some embodiments the inner slope thickness of the aperture wideningzone is less than 100 microns of added thickness per mm. In someembodiments the inner slope thickness of the aperture widening zone isless than 150 microns of added thickness per mm. In some embodiments theinner slope thickness of the aperture widening zone is less than 200microns of added thickness per mm. In some embodiments the inner slopethickness of the aperture widening zone is less than 300 microns ofadded thickness per mm.

In some embodiments the aperture widening zone has a bump on the convexsurface of the prosthesis. In some embodiments the bump is locatedvertically above and below the geometrical center of the prosthesis.

FIGS. 70A-75 illustrate the aperture widening effect of prosthesesaccording to some embodiments. FIGS. 70A and 70B show a comparisonbetween a set of youthful looking eyes 7000 a and a set of eyes havingone eye that droops 7000 b. FIG. 70A shows eyes 7000 a having eyelids7002 a, irises 7004 a, and pupils 7006 a. Eyes 7000 a have a youthfullook because the vertical dimension 7010 a of the eyes' naturalpalpebral fissure is relatively large. Vertical dimension 7010 a foreach eye may be, for example, 10.5 mm. FIG. 70B shows a set of eyes 7000b having eyelids 7002 b, irises 7004 b, and pupils 7006 b. In contrastto FIG. 70A, the right eye in FIG. 70B has a smaller natural palpebralfissure vertical dimension 7012 b, when compared to both the verticaldimension 7010 b of the left eye and vertical dimensions 7010 a ofyouthful eyes 7000 a. This is due the eyelid 7002 b of the right eyedropping downward. This downward droop may have various causes, such as,for example, old age or a medical condition such as ptosis or Bell'sPalsy. The downward droop of right eyelid 7002 b may be 1.0 mm or more.In some instances, the downward droop may be so severe that right eyelid7002 b overlaps iris 7006 b thus interfering with the individual'svision.

FIGS. 71A and 71B show a comparison between a set of youthful lookingeyes 7100 a and a set of eyes having two droopy eyes 7100 b. FIG. 71Ashows eyes 7100 a having eyelids 7102 a, irises 7104 a, and pupils 7106a. Eyes 7100 a have a youthful look because the vertical dimension 7110a of the eyes' natural palpebral fissure is relatively large. Verticaldimension 7110 a for each eye may be, for example, 10.5 mm. FIG. 71Bshows a set of eyes 7100 b having eyelids 7102 b, irises 7104 b, andpupils 7106 b. In contrast to FIG. 71A, both eyes in FIG. 71B have asmaller natural palpebral fissure vertical dimension 7110 b. This is duethe eyelid 7102 b of each eye dropping downward. This downward droop mayhave various causes, such as, for example, old age, tiredness, ptosis orBell's Palsy. The downward droop of eyes 7100 b may be 1.5 mm or more.In some instances, the downward droop may be so severe that eyelids 7102b overlap irises 7106 b thus interfering with the individual's vision.

FIG. 72 shows eyes 7000 b, but in contrast to FIG. 70B, a prosthesis7202 according to one embodiment has been placed on the right eye.Prosthesis 7202 includes a peripheral edge 7204 and an aperture wideningzone having a maximum added thickness delta 7206 in the shape of a ringhaving an aperture widening zone diameter 7220. As shown in FIG. 72,prosthesis 7202 increases the vertical dimension 7210 of the palpebralfissure for the right eye such that is substantially equal to verticaldimension 7010 b of the left eye (e.g., lifts the right eyelid byapproximately 1.0 mm). As illustrated in FIG. 72, peripheral edge 7204may be located underneath eyelid 7002 b when prosthesis 7202 is placedon the right eye. Also, aperture widening zone diameter 7220 may largerthan vertical dimension 7210. In such embodiments, the aperture wideningzone having maximum added thickness delta 7206 may lift and/or depresseyelids 7002 b at the superior tarsus of eyelids 7002 b. In someembodiments, aperture widening zone diameter 7220 may be larger than thediameter of the limbus of the eyes 7000 b.

FIG. 73 shows eyes 7100 b, but in contrast to FIG. 71B, prostheses 7302according to one embodiment have been placed on eyes 7100 b. Prostheses7302 both include a peripheral edge 7304 and an aperture widening zonehaving a maximum added thickness delta 7306 in the shape of a ringhaving a aperture widening zone diameter 7320. Prostheses 7302 may bethe same or different.

As shown in FIG. 73, prosthesis 7302 increases the vertical dimension7310 of the palpebral fissure for each eye such that it is substantiallyequal to vertical dimension 7110 a of youthful eyes 7100 a in FIG. 71A(e.g., lifts the upper eyelids by approximately 1.5 mm). As illustratedin FIG. 73, peripheral edges 7304 may be located underneath eyelids 7102b when prostheses 7302 are placed on eyes 7100 b. Also, aperturewidening zone diameter 7320 may larger than vertical dimension 7310. Insuch embodiments, the aperture widening zone having maximum addedthickness delta 7306 may lift and/or depress eyelids 7102 b at thesuperior tarsus of eyelids 7102 b. In some embodiments, aperturewidening zone diameter 7320 may be larger than the diameter of thelimbus of the eyes 7100 b.

FIG. 74 shows eyes 7100 b, but in contrast to FIG. 71B, prostheses 7402according to one embodiment have been placed on eyes 7100 b. Prostheses7402 both include a peripheral edge 7404, an aperture widening zonehaving a maximum added thickness delta 7406 in the shape of a ringhaving a aperture widening zone diameter 7420, and a color enhancingregion 7408. Color enhancing regions 7408 are colored rings sized andshaped (dimensioned) to surround irises 7104 b. Color enhancing regions7408 may be located on the concave surface or convex surface ofprostheses 7402. In some embodiments, color enhancing regions 7408 maybe buried within prostheses 7402 between the concave surface and theconvex surface. Prostheses 7402 may be the same or different.

As shown in FIG. 74, prostheses 7402 increase the vertical dimension7410 of the palpebral fissure for each eye such that is substantiallyequal to vertical dimension 7110 a of youthful eyes 7100 a in FIG. 71A(e.g., by lifting the upper eyelids by approximately 1.5 mm). Asillustrated in FIG. 74, peripheral edges 7404 may be located underneatheyelids 7102 b when prostheses 7402 are placed on eyes 7100 b. Also,aperture widening zone diameter 7420 may larger than vertical dimension7410. In such embodiments, the aperture widening zone having maximumadded thickness delta 7406 may lift and/or depress eyelids 7102 b at thesuperior tarsus of eyelids 7102 b. In some embodiments, aperturewidening zone diameter 7420 may be larger than the diameter of thelimbus of the eyes 7100 b. In addition to the aperture widening zonephysically increasing vertical dimension 7410 of the palpebral fissures,color enhancing region 7408 may make vertical dimension 7410 appearlarger than its actual dimension. As a non-limiting example, the coloredring surrounding irises 7104 b may enhance the appearance of irises 7104b, thereby making them look larger.

The combination of the widening effect of the aperture widening zone anda color enhancing region (e.g., color enhancing region 7408) may make anindividual's eye(s) look even larger than just an aperture widening zoneor color enhancing region alone. This is due to the upper and/or lowerlid not covering as much of the colored ring of the contact lens beingworn. The perceived widening effect is exaggerated by lifting up theupper lid and/or lowering the lower lid, thereby exposing more of thecolor enhancing region of the prosthesis. Thus, not only does thewearer's eye get physically larger, the iris of the eye looks larger andthe combination of the two provides an effect that appears somewhat morepronounced than what would have been anticipated.

In some embodiments a colored enhancing region (e.g., color enhancingregion 7408) may also function as an aperture widening zone. In suchembodiments, the color enhancing region may provide increased surfacefriction (e.g., friction drag coefficient) to a portion of the convexsurface of the lens. In some embodiments, the color enhancing region mayinclude area are of increased surface friction located on the convexsurface of the prosthesis and separately another surface feature mayprovide an area of incremental thickness, where both the increasedsurface friction of the color enhancing region and the incrementalthickness serve to widen the natural palpebral fissure of an eye.

FIG. 75 shows eyes 7100 b, but in contrast to FIG. 71B, prostheses 7502according to one embodiment have been placed on eyes 7100 b. Prostheses7502 both include a peripheral edge 7504, an aperture widening zonehaving a maximum added thickness delta 7506 in the shape of a ringhaving a aperture widening zone diameter 7520, and a color enhancingregion 7508. Color enhancing regions 7508 are color accent sized andshaped (dimensioned) to overlap irises 7104 b. Color enhancing regions7508 may be located on the concave surface or convex surface ofprostheses 7502. In some embodiments, color enhancing regions 7508 maybe buried within prostheses 7502 between the concave surface and theconvex surface. Prostheses 7502 may be the same or different.

As shown in FIG. 75, prostheses 7502 increase the vertical dimension7510 of the palpebral fissure for each eye such that is substantiallyequal to vertical dimension 7110 a of youthful eyes 7100 a in FIG. 71A(e.g., by lifting the upper eyelids by approximately 1.5 mm). Asillustrated in FIG. 75, peripheral edges 7504 may be located underneatheyelids 7102 b when prostheses 7502 are placed on eyes 7100 b. Also,aperture widening zone diameter 7520 may larger than vertical dimension7510. In such embodiments, the aperture widening zone having maximumadded thickness delta 7506 may lift and/or depress eyelids 7102 b at thesuperior tarsus of eyelids 7102 b. In some embodiments, aperturewidening zone diameter 7520 may be larger than the diameter of thelimbus of the eyes 7100 b. In addition to the aperture widening zonephysically increasing vertical dimension 7510 of the palpebral fissures,color enhancing region 7508 may make vertical dimension 7510 appearlarger than its actual dimension. As a non-limiting example, the coloredaccent overlapping irises 7104 b may enhance the appearance of irises7104 b, thereby making them look larger.

Color enhancing regions of the prosthesis described herein may havevarious sizes, shapes, and configurations. FIG. 76A shows a prosthesis7600 having a color enhancing region 7608 according to an embodiment.Color enhancing region 7608 may be a colored ring having an outerdiameter smaller than the aperture widening zone diameter 7606 ofprosthesis 7600. In some embodiments, color enhancing region 7608 mayoverlap, either partially or fully, with the aperture widening zone ofprosthesis 7600.

FIG. 76B shows a prosthesis 7620 having a color enhancing region 7628according to an embodiment. Color enhancing region 7628 may be a coloraccent region in the form of a ring. As shown in FIG. 76B, colorenhancing region may include multiple colors (or shades of colors)designed to enhance the iris of the eye of a wearer. In someembodiments, color enhancing region 7628 may overlap, either partiallyor fully, with the aperture widening zone of prosthesis 7620. Forexample, as shown in FIG. 76C, a color enhancing region 7648 similar tocolor enhancing region 7628 may be positioned on prosthesis 7640 tooverlap with the aperture widening zone diameter 7648 of prosthesis7640.

While the aperture widening zones in FIGS. 72-76 are discussed asincluding rings having an aperture widening zone diameter, anyconfiguration of aperture widening discussed herein may be utilized towiden the natural palpebral fissure of the eyes illustrated in FIGS. 70Band 71B.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections (if any), is intended to be used tointerpret the claims. The Summary and Abstract sections (if any) may setforth one or more but not all exemplary embodiments of the invention ascontemplated by the inventor(s), and thus, are not intended to limit theinvention or the appended claims in any way.

While the invention has been described herein with reference toexemplary embodiments for exemplary fields and applications, it shouldbe understood that the invention is not limited thereto. Otherembodiments and modifications thereto are possible, and are within thescope and spirit of the invention. For example, and without limiting thegenerality of this paragraph, embodiments are not limited to the,hardware, methods and/or entities illustrated in the figures and/ordescribed herein. Further, embodiments (whether or not explicitlydescribed herein) have significant utility to fields and applicationsbeyond the examples described herein.

Embodiments have been described herein with the aid of functionalbuilding blocks illustrating the implementation of specified functionsand relationships thereof. The boundaries of these functional buildingblocks have been arbitrarily defined herein for the convenience of thedescription. Alternate boundaries can be defined as long as thespecified functions and relationships (or equivalents thereof) areappropriately performed. Also, alternative embodiments may performfunctional blocks, steps, operations, methods, etc. using orderingsdifferent than those described herein.

References herein to “one embodiment,” “an embodiment,” “an exampleembodiment,” or similar phrases, indicate that the embodiment describedmay include a particular feature, structure, or characteristic, butevery embodiment may not necessarily include the particular feature,structure, or characteristic. Moreover, such phrases are not necessarilyreferring to the same embodiment. Further, when a particular feature,structure, or characteristic is described in connection with anembodiment, it would be within the knowledge of persons skilled in therelevant art(s) to incorporate such feature, structure, orcharacteristic into other embodiments whether or not explicitlymentioned or described herein.

The breadth and scope of the invention should not be limited by any ofthe above-described exemplary embodiments, but should be defined only inaccordance with the following claims and their equivalents.

What is claimed is:
 1. A prosthesis capable of being worn on the eye ofa wearer, comprising: a convex surface; a concave surface; and anaperture widening zone located on the convex surface and including anarea of increased surface friction, wherein the area of increasedsurface friction is flat and takes on the normal curvature of the convexsurface of the prosthesis; wherein the aperture widening zone has aminimum vertical dimension of greater than or equal to 8 mm; and whereinthe aperture widening zone is configured to widen the natural palpebralfissure of a wearer's eye.
 2. The prosthesis of claim 1, wherein thearea of increased surface friction has a friction drag coefficient thatis greater than the friction drag coefficient of a portion of the convexsurface adjacent to the area of increased surface friction.
 3. Theprosthesis of claim 1, wherein the area of increased surface frictionhas a friction drag coefficient at least 25% greater than the frictiondrag coefficient of a portion of the convex surface adjacent to the areaof increased surface friction.
 4. The prosthesis of claim 1, wherein thearea of increased surface friction has a friction drag coefficient atleast 33% greater than the friction drag coefficient of a portion of theconvex surface adjacent to the area of increased surface friction. 5.The prosthesis of claim 1, wherein the aperture widening zone includes aplurality of areas of increased surface friction.
 6. The prosthesis ofclaim 1, wherein the prosthesis has an overall diameter of at least 13.0mm.
 7. The prosthesis of claim 1, wherein the area of increased surfacefriction has a minimum vertical dimension of greater than or equal to 8mm.
 8. The prosthesis of claim 1, wherein the area of increased surfacefriction is provided by a surface treatment, a coating, a differentmaterial, surface dimples, surface irregularities, chemical treatment,etching, or a combination thereof.
 9. The prosthesis of claim 1, furthercomprising a color enhancing region.
 10. The prosthesis of claim 9,wherein the color enhancing region provides increased surface friction.11. The prosthesis of claim 9, wherein the color enhancing region atleast partially overlaps with the aperture widening zone.
 12. Theprosthesis of claim 9, wherein the color enhancing region comprises atleast one of: a continuous colored ring, a non-continuous colored ring,a colored zone, a uniform color, multiple colors, multiple shades of asingle color, and an accent color.
 13. The prosthesis of claim 1,wherein the aperture widening zone also includes an area of increasedthickness, and wherein the area of increased thickness includes an outerslope and an inner slope with a maximum change in thickness located inbetween.
 14. The prosthesis of claim 13, wherein the maximum change inthickness is between 25 microns and 1,000 microns.
 15. The prosthesis ofclaim 1, wherein the entire area of increased surface friction is flatand takes on the normal curvature of the convex surface of theprosthesis.